HORIBA INSTRUMENTS INCORPORATED

FDA Device Registration & Listing · Canton, MI, US · Registration 1827821

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1827821
FEI Number
1827821
Entity Name
HORIBA INSTRUMENTS INCORPORATED
City/State/Country
Canton, MI, US
Establishment Address
5449 Research Dr, Canton, MI 48188, US
Establishment Type(s)
Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical (Owner Number: 10083022)
Owner / Operator Contact Address
9755 Research Drive, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K042318
PMA Number
N/A

All Registered Proprietary Names

L7574, Pointe autoLDL Cholesterol Reagent A7516 Pointe Alkaline Phosphatase Reagent P7516-STD, Pointe Phosphorus Standard P7516, HP916, Pointe Inorganic Phosphorus Reagent (UV) C7510, Pointe Cholesterol Reagent C7509-STD, Pointe Cholesterol Standard 60-MB0748 Pointe Carisporodol Metabolite (SOMA) (200 ng/mL) Intermediate 60-MB0746 Pointe Carisporodol Metabolite (SOMA) Calibrator (100 ng/mL) Cutoff 60-NF0626 Pointe Norfentanyl Calibrator (5 ng/mL) 60-MB0744 Pointe Carisporodol Metabolite (SOMA) Calibrator (50 ng/mL) Low 60-MB0750 Pointe Carisporodol Metabolite (SOMA) (400 ng/mL) High A7503 Pointe Acid Phosphatase Reagent T8005, Pointe CMV IgG Enzyme Immunoassay S1115, Pointe Testosterone Enzyme Immunoassay A7567 Pointe ASO Reagent HU982, U7581, Pointe Uric Acid Reagent S1113, Pointe Progesterone Enzyme Immunoassay H7546 Pointe Hemoglobin A1c Reagent H7541 Pointe Hemoglobin A1c Reagent H7541-CTL Pointe Hemoglobin A1c Controls H7541-CAL Pointe Hemoglobin A1c Calibrator C7509-STD, Pointe Cholesterol Standard G7521 Pointe Liquid Glucose (Oxidase) Reagent Pointe 180 QT Chemistry Analyzer Pointe 180 Plus Chemistry Analyzer Pointe 180 II Chemistry Analyzer A7504, Pointe Alcohol Reagent T7535 Pointe Transferrin Reagent I7517, Pointe Direct TIBC Reagent C7522 Pointe Liquid Creatine Kinase Reagent (CK) 60-OX0494 Pointe Oxycodone Control (375 ng/mL) 60-OX0484 Pointe Oxycodone Control (75 ng/mL) 60-OX0488 Pointe Oxycodone Control (125 ng/mL) 60-OX0504 Pointe Oxycodone Calibrator (50 ng/mL) 60-OX0490 Pointe Oxycodone Control (225 ng/mL) 60-OX0486 Pointe Oxycodone Calibrator (100 ng/mL) 60-OX0480 Pointe Oxycodone Reagent 60-OX0492 Pointe Oxycodone Calibrator (300 ng/mL) 60-OX0498 Pointe Oxycodone Calibrator (800 ng/mL) 60-OX0496 Pointe Oxycodone Calibrator (500 ng/mL) M7562-CTL, Pointe Microalbumin Controls 60-HY0774 Pointe Hydrocodone 100 Level 1 Control (75 ng/mL) 60-HY0770 Pointe Hydrocodone 100 Calibrator (300 ng/mL) 60-HY0790 Pointe Hydrocodone 300 Calibrator (800 ng/mL) 60-HY0766 Pointe Hydrocodone 100 Calibrator (100 ng/mL) 60-HY0784 Pointe Hydrocodone 300 Calibrator (150 ng/mL) 60-HY0780 Pointe Hydrocodone 300 Reagent 60-HY0768 Pointe Hydrocodone 100 Calibrator (150 ng/mL) 60-HY0794 Pointe Hydrocodone 300 Level 1 Control (225 ng/mL) 60-HY0786 Pointe Hydrocodone 300 Calibrator (300 ng/mL) 60-HY0796 Pointe Hydrocodone 300 Level 2 Control (375 ng/mL) 60-HY0760 Pointe Hydrocodone 100 Reagent 60-HY0764 Pointe Hydrocodone 100 Calibrator (50 ng/mL) 60-HY0788 Pointe Hydrocodone 300 Calibrator (500 ng/mL) 60-H70776 Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) H7506-CTL Pointe Hemoglobin Controls 60-AM0216 Pointe Amphetamines 500 Level 2 Control (MAMP 625 ng/mL) 60-AM0206 Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL) 60-AM0204 Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL) 60-AM0208 Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL) 60-AM0210 Pointe Amphetamines 500 Calibrator (MAMP 2000 ng/mL) 60-AM0200 Pointe Amphetamines 500 Reagent 60-AM0214 Pointe Amphetamines 500 Level 1 Control (MAMP 375 ng/mL) L7572, HL956, Pointe Lactate Dehydrogenase Reagent (LD) 60-MA1796 Pointe Multi-Analyte Set E DAU Level 2 Control 60-MA1754 Pointe Multi-Analyte Set D Urine DAU Level 1 Control 60-MA1756 Pointe Multi-Analyte Set D Urine DAU Level 2 Control 60-MA1794 Pointe Multi-Analyte Set E DAU Level 1 Control C7529 Pointe Calcium Arsenazo III Reagent G7540-STD, Pointe Glycohemoglobin Standard G7540-CTL, Pointe Glycohemoglobin Controls A7526 Pointe Liquid ALT (SGPT) Reagent P1035, Pointe Immunoglobulin E (IgE) Enzyme Immunoassay (EIA) H7588-CAL B-Hydroxbutyrate Calibrator H7588-CTL B-Hydroxybutyrate Controls H7588 B-Hydroxybutyrate Reagent A7505 Pointe Alkaline Phosphatase Reagent T1005, Pointe Triiodothyronine (T3) Enzyme Immunoassay (EIA) Pointe Impulse Chemistry Analyzer L7513-CTL Lipase Controls L7513 Lipase Reagent L7513-STD Lipase Standard B7552 Pointe Liquid Urea Nitrogen (BUN) Reagent RA502-CTL Pointe RF/ASO Controls C7502 Pointe Carbon Dioxide Reagent C7502-STD Pointe Carbon Dioxide Standard CM1117, Pointe Myoglobin Enzyme Immunoassay (EIA) T7535-CAL Pointe Transferrin Calibrators 60-MA1706 Pointe Multi-Analyte Set C Urine DAU Cutoff Calibrator 60-MA1708 Pointe Multi-Analyte Set C Urine DAU Intermediate Calibrator 60-MA1704 Pointe Multi-Analyte Set C Urine Low Calibrator 60-MA1716 Pointe Multi-Analyte Set C Urine DAU Level 2 Control 60-UN0002 Pointe Universal Negative Calibrator 60-MA1710 Pointe Multi-Analyte Set C Urine DAU High Calibrator 60-MA1714 Pointe Multi-Analyte Set C Urine DAU Level 1 Control T1007, Pointe Total Thyroxine (T4) Enzyme Immunoassay (EIA) 60-MA1782 Pointe Multi-Analyte Set E DAU Negative Calibrator 60-MA1742 Pointe Multi-Analyte Set D Urine DAU Negative Calibrator 60-MA1748 Pointe Multi-Analyte Set D Urine DAU Intermediate Calibrator 60-MA1744 Pointe Multi-Analyte Set D Urine DAU Low Calibrator 60-MA1784 Pointe Multi-Analyte Set E DAU Low Calibrator 60-MA1790 Pointe Multi-Analyte Set E DAU High Calibrator 60-MA1786 Pointe Multi-Analyte Set E DAU Cutoff Calibrator 60-MA1746 Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator 60-MA1750 Pointe Multi-Analyte Set D Urine DAU High Calibrator 60-MA1788 Pointe Multi-Analyte Set E DAU Intermediate Calibrator 60-OP0040 Pointe Opiate 300 Reagent Mindray BS480 Chemistry Analyzer Yumizen C560 Chemistry Analyzer C7585-CAL Cystatin C Calibrator C7585-CTL Cystatin C Controls C7585 Cystatin C Reagent T8004, Pointe Rubella IgM Enzyme Immunoassay B7576 Pointe Total Bilirubin Reagent A7504-STD, Pointe Alcohol Standard 60-CC0060 Pointe Cocaine Metabolite Reagent A7567 Pointe ASO Calibrator G7571, HG959, Pointe GGT (y-glutamyl transferase) Reagent Pointe Lipid Control Set LPA400C Lipoprotein (a) Calibrator LPA400CR Lipoprotein (a) Calibrator LPA400 Lipoprotein (a) A7527 ALT Single Reagent F1031, Pointe Luteinizing Hormone (LH) Enzyme Immunoassay T7531, T7532, Pointe Triglyceride (GPO) Reagent T1008, Pointe Free Thyroxine (fT4) Enzyme Immunoassay (EIA) T8001, Pointe Toxoplasma IgG Enzyme Immunoassay A7564, Pointe Liquid Amylase (CNPG3) Reagent T7535-CTL Pointe Transferrin Controls C7562-CTL, Pointe CK-MB Controls B7554 Pointe BUN Reagent Mindray BA800 Chemistry Analyzer H7511, Pointe HDL Cholesterol Precipitating Reagent ABX Minotrol 16 Whole Blood Hematology Controls (5300100303, 5300100306, 5300100312) BFTROL T8002, Pointe Toxoplasma IgM Enzyme Immunoassay C7548, Pointe Creatinine (Enzymatic) Reagent 60-EA0440 Pointe Ethyl Alcohol Reagent 60-EA0448 Pointe Ethyl Alcohol Level 1 Control (50 mg/dL) 60-EA0450 Pointe Ethyl Alcohol Level 2 Control (300 mg/dL) 60-EA0446 Pointe Ethyl Alcohol Calibrator (100 mg/dL) T7531-STD, Pointe Triglyceride Standard G7540, Pointe Glycohemoglobin Reagent I7517-CAL, Pointe Direct TIBC Calibrator T1001, Pointe Thyroid Stimulating Hormone (TSH) Enzyme Immunoassay (EIA) B7551, Pointe Urea Nitrogen (BUN) (Berthelot/Colorimetric) HB979 Pointe Total Bilirubin Reagent HB936 Pointe Direct Bilirubin Reagent 60-FN0620 Pointe Fentanyl (Qualitative) Reagent U7580-STD, Pointe Uric Acid Standard U7580, Pointe Uric Acid Reagent F1037, Pointe Prolactin Immunoassay C7506-DIL Pointe Chemistry Diluent C7506-CAL Pointe Chemistry Calibrator G7517, Pointe Glucose (Hexokinase) Reagent H7545, Pointe Liquid autoHDL Choldesterol Reagent H7545-CAL, Pointe autoHDL/LDL Cholesterol Calibrator 60-PH0020 Pointe Phencyclidine Reagent A7504-CTL, Pointe Ammonia / Alcohol Control Set T1006 Pointe Free T3 EIA 60-NB0546 Pointe Norbuprenorphine Low/Cutoff Calibrator (5 ng/mL) 60-NB0556 Pointe Norbuprenorphine Intermediate Calibrator #2 (40 ng/mL) 60-NB0548 Pointe Norbuprenorphine Level 1/Level 2 Control (7 ng/mL) 60-NB0544 Pointe Norbuprenorphine Level 1 Control (3 ng/mL) 60-NB0550, Pointe Norbuprenorphine Cutoff Calibrator #2 (10 ng/mL) 60-NB0554 Pointe Norbuprenorphine Intermediate Calibrator #1 (20 ng/mL) 60-BP0540, Pointe Buprenorphine Reagent 60-NB0558 Pointe Norbuprenorphine High Calibrator (75 ng/mL) 60-NB0552 Pointe Norbuprenorphine Level 2 Control (13 ng/mL) A7502 Pointe Albumin Reagent A7502-STD Pointe Albumin Standard Mindray BS200 Chemistry Analyzer Pointe C2000 Chemistry Analyzer 60-BZ0266 Pointe Benzodiazepine Calibrator/Control (Oxazepam 200 ng/mL) 60-BZ0272 Pointe Benzodiazepine Control (Oxazepam 400 ng/mL) 60-BZ0264 Pointe Benzodiazepine Calibrator/Control (Oxazepam 100 ng/mL) 60-BZ0260 Pointe Benzodiazepine Reagent 60-BZ0268 Pointe Benzodiazepine Calibrator/Control (Oxazepam 300 ng/mL) 60-BZ0270 Pointe Benzodiazepine Calibrator (Oxazepam 1000 ng/mL) T7528-STD Pointe Total Protein Standard T7528, HT928, Pointe Total Protein (Biuret) Reagent L7596, Pointe Lactate Reagent L7596-STD, Pointe Lactate Standard 60-EC0334 Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1 60-EC0330 Pointe Ecstasy (MDMA) Calibrator (1000 ng/mL) High 60-EC0324 Pointe Ecstasy (MDMA) Calibrator (100 ng/mL) Low 60-EC0336 Pointe Ecstasy (MDMA) Control (625 ng/mL) Level 2 60-EC0320 Pointe Ecstasy (MDMA) Reagent 60-EC0328 Pointe Ecstasy (MDMA) Calibrator (750 ng/mL) Intermediate 60-EC0326 Pointe Ecstasy (MDMA) Calibrator (500 ng/mL) Cutoff H7575-CTL, Pointe Homocysteine Controls 60-MP0708 Pointe Methamphetamine Calibrator (1000 ng/mL) Intermediate 60-MP0700 Pointe Methamphetamine Reagent 60-MP0710 Pointe Methamphetamine Calibrator (2000 ng/mL) High 60-MP0716 Pointe Methamphetamine Control (625 ng/mL) Level 2 60-MP0706 Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff 60-MP0714 Pointe Methamphetamine Control (375 ng/mL) Level 1 60-MP0704 Pointe Methamphetamine Calibrator (250 ng/mL) Low H7575, Pointe Homocysteine Reagent H7575-CAL, Pointe Homocysteine Calibrator A7562 Pointe AST Single Reagent C7504-STD, Carbon Dioxide Standard 60-ME0224 Pointe Methadone Calibrator (150 ng/mL) 60-PP0256 Pointe Propoxyphene Control (375 ng/mL) Level 2 60-ME0226 Pointe Methadone Calibrator (300 ng/mL) 60-ME0234 Pointe Methadone Level 1 Control (225 ng/mL) 60-PP0254 Pointe Propoxyphene Control (225 ng/mL) Level 1 60-PP0250 Pointe Propoxyphene Calibrator (1000 ng/mL) High 60-PP0244 Pointe Propoxyphene Calibrator (150 ng/mL) Low 60-PP0248 Pointe Propoxyphene Calibrator (600 ng/mL) Intermediate 60-ME0230 Pointe Methadone Calibrator (1000 ng/mL) 60-ME0228 Pointe Methadone Calibrator (600 ng/mL) 60-ME0236 Pointe Methadone Level 2 Control (375 ng/mL) 60-PP0246 Pointe Propoxyphene Calibrator (300 ng/mL) Cutoff CM1105, Pointe Troponin I (Human Cardiac Specific) EIA Test Kit M7562-CAL, Pointe Microalbumin Multi-Calibrator M7562, Pointe Microalbumin Reagent 60-ME0220 Pointe Methadone Reagent F1029, Pointe Follicle-Stimulation Hormone (FSH) Enzyme Immunoassay 60-BA0286 Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL) 60-BA0290 Pointe Barbiturate Calibrator (Secobarbital 1000 ng/mL) 60--BA0288 Pointe Barbiturate Calibrator/Control (Secobarbital 300 ng/mL) 60-BA0292 Pointe Barbiturate Control (Secobarbital 400 ng/mL) 60-BA0280 Pointe Barbiturate Reagent 60-BA0284 Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL) 60-TH0148 Pointe THC Control (31.25 ng/mL) 60-CA0140 Pointe Cannabinoid (THC) Reagent 60-TH0004 Pointe THC Negative Calibrator (0 ng/mL) 60-TH0014 Pointe THC Calibrator/Control (37.5 ng/mL) 60-TH0152 Pointe THC Calibrator/Control (75 ng/mL) 60-TH0016 Pointe THC Control (62.5 ng/mL) 60-TH0144 Pointe THC Calibrator (12.5 ng/mL) 60-TH0146 Pointe THC Calibrator (25 ng/mL) 60-TH0154 Pointe THC Calibrator (100 ng/mL) 60-TH0158 Pointe THC Calibrator (200 ng/mL) 60-TH0012 Pointe THC Control (18.75 ng/mL) 60-TH0150 Pointe THC Calibrator (50 ng/mL) 60-TH0018 Pointe THC Control (125 ng/mL) 60-TH0156 Pointe THC Calibrator (150 ng/mL) 60-CM0740 Pointe Carisporodol Metabolite (SOMA) Reagent B7550-STD Pointe BUN Standard HM929, Pointe Magnesium Reagent M7527-STD, Pointe Magnesium Standard R7502 Pointe Rheumatoid Factor (RF) Reagent R7502-CAL Pointe Rheumatoid Factor (RF) Calibrators 60-MM0384 Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low 60-MM0406 Pointe Methadone Metabolite (EDDP) Calibrator (100 ng/mL) Cutoff 60-MM0386 Pointe Methadone Metabolite (EDDP) Calibrator (300 ng/mL) Cutoff 60-MM0388 Pointe Methadone Metabolite (EDDP) Calibrator (600 ng/mL) Intermediate 60-MM0380 Pointe Methadone Metabolite (EDDP) Reagent 60-MM0408 Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate 60-MM0404 Pointe Methadone Metabolite (EDDP) Calibrator (50 ng/mL) Low 60-MM0390 Pointe Methadone Metabolite (EDDP) Calibrator (1000 ng/mL) High 60-MM0410 Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High S1111, Pointe Estradiol (E2) Enzyme Immunoassay T1003, Pointe Ultra-Sensitive Thyroid Stimulating Hormone (U-TSH) EIA L7580-CTL, Pointe Lipid Controls B7538, Pointe Direct Bilirubin Reagent 60-PP0240 Pointe Propoxyphene Reagent C7513-STD Pointe Creatinine Standard C7539 Pointe Creatinine Reagent F1027, Pointe Human Chorionic Gonadotropin (hCG) EIA Test Kit H7590, HDL Reagent C7592, Pointe Chemistry Controls, Level 1 and Level 2 C7591, Pointe Chemistry Control, Level 2 C7590, Pointe Chemistry Control, Level 1

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2021-11-22
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2021-11-19
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2021-11-22
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2021-11-22
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
JFH Acid Phosphatase (Prostatic), Tartrate Inhibited Clinical Chemistry Class 2 862.1020 2021-11-19
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2021-11-23
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2021-11-23
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 2024-03-18
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2021-11-22
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 2021-11-23
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2021-11-19
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2021-11-24
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2021-11-19
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2021-11-23
DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Clinical Toxicology Class 2 862.3040 2021-11-22
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2023-07-13
JMO Ferrozine (Colorimetric) Iron Binding Capacity Clinical Chemistry Class 1 862.1415 2021-11-22
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2021-11-19
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2021-11-22
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2021-11-19
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2021-11-22
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2021-11-24
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2021-11-19
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2021-11-23
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2021-11-24
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2021-11-23
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2023-01-24
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2021-11-19
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2021-11-23
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2021-11-23
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2021-11-23
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2021-11-23
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2021-11-23
CHI Lipase-Esterase, Enzymatic, Photometric, Lipase Clinical Chemistry Class 1 862.1465 2023-01-24
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2021-11-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2023-07-13
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2021-11-19
DRR Amplifier And Signal Conditioner, Biopotential Cardiovascular Class 2 870.2050 2021-11-22
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2023-07-13
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2021-11-23
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2021-11-23
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2021-11-24
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2021-11-23
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2021-11-23
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2021-11-23
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2021-11-23
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2021-11-23
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2021-11-23
NDY Test, Cystatin C Clinical Chemistry Class 2 862.1225 2023-01-24
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2021-11-23
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2021-11-19
DNN Calibrators, Ethyl Alcohol Clinical Toxicology Class 2 862.3200 2021-11-22
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2021-11-23
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2024-03-18
JQB Kinetic Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 2021-11-22
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2025-03-28
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2022-06-01
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2022-06-01
JJS Controls For Blood-Gases, (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-06-01
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2021-12-28
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2021-11-23
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2021-11-22
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2021-11-23
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2021-11-23
CIJ Saccharogenic, Amylase Clinical Chemistry Class 2 862.1070 2021-11-22
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2023-07-13
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-22
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2021-12-23
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2021-11-23
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2021-11-23
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2021-11-23
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2021-11-23
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2021-11-23
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2021-11-22
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2024-10-21
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2021-11-23
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2021-11-23
DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Clinical Toxicology Class 2 862.3040 2021-11-23
DKC Alcohol Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
DNN Calibrators, Ethyl Alcohol Clinical Toxicology Class 2 862.3200 2021-11-23
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2021-11-23
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2021-11-22
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2021-11-22
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2021-11-23
CDL Berthelot Indophenol, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2021-11-22
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2021-11-19
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2021-11-23
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2021-11-22
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2021-11-23
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2021-11-19
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2021-11-23
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2021-11-22
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2021-11-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-22
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2021-12-23
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2021-11-23
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2021-11-19
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2021-11-23
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2021-11-23
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2021-11-23
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2021-11-23
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2021-11-23
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2021-11-22
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2021-11-23
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2021-11-23
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2021-11-23
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-24
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2021-11-24
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-24
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2021-11-23
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2021-11-23
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2021-12-23
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2021-12-28
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-24
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-24
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2021-11-22
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2021-11-23
DDZ Albumin, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5040 2021-11-23
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2021-11-23
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2021-11-23
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2021-11-23
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2021-11-23
QBK Meprobamate Test System Clinical Toxicology Class 2 862.3590 2021-11-24
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2021-12-23
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2021-11-22
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2023-07-13
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2023-07-13
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2021-11-23
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2021-11-23
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2021-11-23
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2021-11-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-23
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2021-11-22
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2021-11-23
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2021-11-19
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2021-11-22
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2021-11-23
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2021-11-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2086725 HORIBA INSTRUMENTS INCORPORATED IRVINE, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K790947 Macomb Chemical Co. AUTO ENZYMATIC CHOLESTEROL 1979-06-28
K885023 Em Diagnostic Systems, Inc. CHOLESTEROL TEST ITEM NUMBER: SR1011 1989-02-17
K771508 Instrumentation Laboratory CO MULTISTAT III CHOLESTEROL TEST 1977-09-13
K780731 Vitek Systems, Inc. LIDOCAINE CALIBRATOR KIT 1979-01-17
K833380 E.I. Dupont DE Nemours & Co., Inc. LIDOAINE CALIBRATOR 1983-12-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2009 Roche Diagnostics Corp. 1
Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.
Z-0020-2014 Abbott Laboratories, Inc 1
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

Similar Registrations

Registration Number Establishment Name Location
3013660430 High Technology, Inc. North Attleboro, MA, US
9610529 ROCHE DIAGNOSTICS GMBH PENZBERG Bavaria, DE
1319808 ORTHO-CLINICAL DIAGNOSTICS, INC. Rochester, NY, US
2247288 ALFA WASSERMANN West Caldwell, NJ, US
3003356736 MERCODIA AB UPPSALA, SE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1827821. Last updated year: 2026. Please use registration number 1827821 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.