Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1832216

FEI Number

1832216

Entity Name

TECO DIAGNOSTICS

City/State/Country

ANAHEIM, CA, US

Establishment Address

1268 NORTH LAKEVIEW AVE., ANAHEIM, CA 92807, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TECO DIAGNOSTICS (Owner Number: 1832216)

Owner / Operator Contact Address

1268 NORTH LAKEVIEW AVE., --, Anaheim, CA 92807, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K863927

PMA Number

N/A

All Registered Proprietary Names

ALKALINE PHOSPHATASE Teco Menopause Stage Indicator FSH Test CK-MB (NAC), Kinetic Amphetamine Card/Dipstick Test Glycohemoglobin URINE REAGENT STRIP-3 GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM CLIAWAIVED URS-1G JorVet URS-1G Pulse Scientific Inc URS-1G Cortez Diagnostics URS-1G LW Scientific URS-1G IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET Alkaline Phosphatase Color CARBON DIOXIDE (CO2) URIC ACID hCG Microtiter Test POTASSIUM REAGENT SET TC-94/96/PLUS Elisa Washer/Reader Troponin I Card Test AlcoCheck Breath Alcohol Test CK-MB 2 Level Control RAPID PLASMA REAGIN (RPR) SET beta-2 Microglobulin Microtiter Test Carbon Dioxide AST/SGOT LIQUID REAGENT - KINETIC METHOD VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE Multiple Drug Scan -5 Cocaine Dipstick Test Glucose, Hexokinase. Liquid Iron/TIBC URS-1M Microalbumin IgE EIA Kit Uric Acid Drug Scan 2 - MDMA/MET Panel IDG RF Cortez RF Rheumatoid Factor (RF) Cortez URS-9 LW Scientific URS-9 URINE REAGENTS STRIPS-9 Nurse Hatty URS-1K KETO MOJO URS-1K URINE REAGENT STRIP-IK (URS-IK) T4/Free T4 Microtiter Test Creatinine, Color, End Point Cholinesterase, Kinetic URS-PBG Creatine Kinase, Color, End Point HbA1c DIRECT ENZYMATIC TEST KIT BUN, Kinetic Gluco Check Basic ALT/SGPT NADH OXIDATION/NAD REDUCTION, ALT/SGPT TROPONIN I EIA KIT TROPONIN I Gluco-Track Calcium CRESOLPHTHALEIN COMPLEXONE, CALCIUM CRP RAPID TEST C-REACTIVE PROTEIN RAPID TEST LIPASE REAGENT SET HDL Cholesterol UREA NITROGEN(BUN), COLORIMETRIC METHOD BUN, Urease, Color, End Point Urine Controls Human Urine level I (Dried) URINE REAGENT STRIPS URINE REAGENT STRIPS Marijuana (THC) Dipstick Test URS-2GP (GLUCOSE PROTEIN) URINE STRIPS VISUAL HCG PREGNANCY TEST One-step combo pregnancy dipstick test ONE STEP MARIJUANA CARD TEST Glucopad TC-Smart+ Lancets Opiates Card Test Drug Scan 6 REAGENT, OCCULT BLOOD Drug Scan 5 - COC/AMP/OPI/PCP/THC Panel Drug Scan 4 - Four Parameter Panel Drug Scan 3 - THC/OPI/BZD Panel Drug Scan 9 - Nine Parameter Panel Drug Scan 8 - Eight Parameter Panel Drug Cup - Multi-Screen 10 Drug Scan 10 - Ten Parameter Panel COC Cocaine Card AMP Amphetamine Card Drug Scan 7 - Seven Parameter Panel THC Marijuana Card BAR Barbiturates Card Drug Scan 5 - MET/AMP/THC/COC/OPI Panel PCP Phencyclidine Card LH Elisa Test kit SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) Triglyceride, GPO LACTATE DEHYDROGENASE LDH-L ONE STEP MORPHINE CARD TEST Testosterone Microtitier Test BZD Benzodiazepine Card BZD Benzodiazepine Dipstick Drug Scan 6 Test Amphetamine Card Test Total T3 Elisa Test kit ACID PHOSPHATASE REAGENT SET TC-Matrix Chemistry Analyzer URITEK TC-101 URINE ANALYZER C-Reactive protein (CRP) IDG CRP Cortez CRP Drug Scan 5 - COC/AMP/OPI/PCP/THC Panel Glycohemoglobin Normal Control Glycohemoglobin Elevated Control MYOGLOBIN EIA KIT Glucopad TC-Smart+ Blood Glucose Monitoring System TOTAL PROTEIN (BIURET) REAGENT SET DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR CLINISTRIP Barbiturate Card/Dipstick Test LACTATE DEHYDROGENASE (LDH-L) URISTAT UTI test strips Teco Diagnostics UTI Test Strips AZO UTI test strips URS-2L Glucose Hexokinase ACTIVATED PARTIAL THROMBOPLASTIN PHOSPHORUS (INORGANIC) Benzodiazepine Card Test Drug Scan 6 Test Pregnancy HCG test midstream GLUCOSE REAGENT SET TC-3300 Analyzer system MAGNESIUM Cliawaived 10SG URS-5OB-100 URS-2P-100 URS-10 Drug Cup - Multi-Screen 10 with Adulteration Strip Drug Cup - Multi-Screen 3 - AMP/COC/OXY INFECTIOUS MONONUCLEOSIS (IML) IDG RPR Cortez RPR Rapid Plasma Reagent (RPR) Copper Control level I Copper Control level II Amylase, Kinetic AST (SGOT) , Kinetic URITEK TC-101 U-TSH Microtiter AST(SGOT) Color Kinetic FSH ELISA Test Kit Uritek TC-201 Urine Chemistry Test System URS-1G (GLUCOSE TEST) Phencyclidine (PCP) Card Test Drug Scan 6 Test HEMOGLOBIN A1C REAGENT SET, CONTROL AND CALIBRATOR MET Methamphetamine Card Infectious Mononucleosis (IM) Cortez IML Marijuana (THC) Card Test Drug Scan 6 Test ANTISTREPTOLYSIN (ASO) BLOOD GLUCOSE MONITORING SYSTEM Tyiglyceride GPO liquid SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) URITEK-720+ URINE ANALYZER TRIGLYCERIDES (GPO-TRINDER) TC-84 analyzer system UREA NITROGEN (BUN) LIQUID REAGENT, KINETIC METHOD MTD Methadone Card CSF/URINE TOTAL PROTEIN LIPASE REAGENT SET Sodium Glucose, Oxidase Cholesterol, Kinetic Liquid CK- NAC, Kinetic Liquid Creatine Kinase - NAC, Kinetic Chloride T3/Free T3 Microtiter Test LACTATE DEHYDROGENASE EXPRESS CLINICAL CHEMISTRY ANALYZER LW Scientific URS-1B URS-1B ALT (SGPT) Kinetic DIRECT LDL CHOLESTEROL COPPER REAGENT SET BIURET (COLORIMETRIC), TOTAL PROTEIN Cortez Diagnostics URS-2K URS-2K ATHENESE URS-2K KISH URS-2K Pulse Scientific Inc URS-2K Cocaine Card Test Drug Scan 6 Test SARS-CoV-2 IgM & IgG Test System CHOLESTEROL (LIQUID) REAGENT SET ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	1992-11-24
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2026-02-02
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2009-03-02
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2009-03-02
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2009-03-02
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2009-03-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2009-03-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-03-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2009-03-02
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2000-02-09
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-03-02
CIO	Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2009-03-02
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2009-03-02
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2017-01-12
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2009-03-02
CEJ	Tetraphenyl Borate, Colorimetry, Potassium	Clinical Chemistry	Class 2	862.1600	2009-03-02
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2009-11-12
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2009-03-02
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2014-05-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-03-02
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2013-06-10
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2009-03-02
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2009-03-02
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2009-03-02
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2006-12-28
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-03-02
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2009-03-02
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2009-03-02
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2009-03-02
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2009-03-02
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2009-03-02
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2009-03-02
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-03-02
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2009-03-02
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2009-03-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2009-04-06
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2009-04-06
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-06-10
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2009-03-02
MVO	Kit, Test, Multiple, Drugs Of Abuse, Over The Counter	Unknown	Class U	N/A	2014-05-19
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2009-03-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2009-03-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2009-03-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2009-03-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2009-03-02
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2009-03-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2000-02-17
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2009-03-02
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2009-03-02
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2009-03-02
JNF	Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen	Clinical Chemistry	Class 1	862.1590	2021-07-01
JHY	Colorimetric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2009-03-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-06-10
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-06-10
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-06-10
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	1992-11-24
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-05-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-05-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-05-19
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	1992-11-24
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2013-06-10
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-03-02
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2009-03-02
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2009-03-02
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2013-06-10
CET	Olive Oil Emulsion (Turbidimetric), Lipase	Clinical Chemistry	Class 1	862.1465	1992-11-24
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2009-03-02
CDL	Berthelot Indophenol, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2009-03-02
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-03-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	1995-12-19
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	1995-08-30
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2009-03-02
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-03-02
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2009-03-02
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2009-03-02
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2009-03-02
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2009-03-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2015-01-20
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2015-01-20
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2013-01-31
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2009-03-02
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2009-03-02
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-05-01
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2025-05-01
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-03-19
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2013-06-10
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2014-05-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2014-05-19
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2014-05-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2014-05-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2014-05-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2014-05-19
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2014-05-19
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2014-05-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2014-05-19
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2009-12-01
DHC	System, Test, Systemic Lupus Erythematosus	Immunology	Class 2	866.5820	2013-06-10
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	1992-11-24
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	1992-11-24
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2009-03-02
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2009-03-02
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2014-05-19
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2014-05-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-03-19
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2009-12-01
CKE	Acid Phosphatase, Thymolphthale Inmonophosphate	Clinical Chemistry	Class 2	862.1020	2006-12-28
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2009-04-02
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2009-04-02
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-04-02
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-04-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-04-02
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2009-04-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2011-02-16
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2011-02-16
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2011-02-16
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2011-02-16
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2011-02-16
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2011-02-16
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2011-02-16
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2011-02-16
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2011-02-16
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2011-02-16
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2011-02-16
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2009-03-02
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2014-05-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2014-05-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2014-05-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2014-05-19
LCL	Radioimmunoassay, Phencyclidine	Unknown	Class U	N/A	2014-05-19
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2009-03-02
DRR	Amplifier And Signal Conditioner, Biopotential	Cardiovascular	Class 2	870.2050	2013-06-10
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2025-05-20
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2025-05-20
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-05-20
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	1983-09-27
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	1992-11-24
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	1992-11-24
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2009-03-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2009-03-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2009-03-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2009-03-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2009-03-02
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2009-03-02
JJR	Electrolyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-03-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2009-03-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-03-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2009-03-02
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2009-03-02
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2009-03-02
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2009-03-02
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2009-03-02
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2009-03-02
CFH	Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2009-03-02
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2011-05-06
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2011-05-06
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-03-02
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2009-03-02
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	1992-11-24
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-03-19
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-08-14
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	1992-11-24
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2006-12-28
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2009-03-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2009-03-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2009-03-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2009-03-02
JJR	Electrolyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-03-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2009-03-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-03-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2009-03-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2009-03-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2009-03-02
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2009-03-02
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2014-05-19
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2013-06-10
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2009-03-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-05-06
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2006-12-28
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2009-03-02
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2009-05-01
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2009-03-02
CIQ	Diazo, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2009-03-02
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2009-12-01
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2017-01-30
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2017-01-30
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2017-01-30
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2017-01-30
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2017-01-30
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2017-01-30
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2017-01-30
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2017-01-30
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2017-01-30
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2017-01-30
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2017-01-30
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2022-06-06
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2012-03-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	1994-02-22
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	1994-02-22
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	1994-02-22
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2014-05-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2014-05-19
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2014-05-19
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2014-05-19
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2014-05-19
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2014-05-19
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2009-03-02
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2012-03-19
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2013-06-10
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-04-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-04-03
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-04-03
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	1988-02-04
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2013-06-10
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2013-06-10
DHC	System, Test, Systemic Lupus Erythematosus	Immunology	Class 2	866.5820	2013-06-10
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2009-03-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2009-03-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2009-03-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-03-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2009-03-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2009-03-02
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2009-03-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2009-03-02
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2009-03-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2009-03-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2009-03-02
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2009-03-02
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2009-03-02
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2009-03-02
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2014-05-19
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2009-03-02
CET	Olive Oil Emulsion (Turbidimetric), Lipase	Clinical Chemistry	Class 1	862.1465	2009-03-02
CEI	Uranyl Acetate/Zinc Acetate, Sodium	Clinical Chemistry	Class 2	862.1665	2009-10-22
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-03-02
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	1992-11-24
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2009-03-02
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Clinical Chemistry	Class 2	862.1170	2009-03-02
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2009-03-02
CFH	Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	1992-11-24
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2006-09-28
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2009-03-02
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2009-03-02
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2006-12-28
JKZ	Diethyldithiocarbamate (Colorimetric), Copper	Clinical Chemistry	Class 1	862.1190	2024-03-19
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	1992-11-24
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2009-03-02
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2012-03-19
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-21
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2009-03-02

Official Correspondent

KC Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TECO DIAGNOSTICS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006621318	Chong Qing Teco Huayi Pharm. Co.	Shapingba Dist., Chongqing, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820880	Miles Laboratories, Inc.	SERALYZER CK REAGENT STRIPS	1982-04-16
K771441	Instrumentation Laboratory CO	MULTISTAT III CPK TEST	1977-08-22
K970265	Drial Consultants, Inc.	ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST	1997-04-08
K051161	Quest Diagnostics, Inc.	QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)	2005-11-22
K122904	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;	2012-11-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

Similar Registrations

Registration Number	Establishment Name	Location
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
1827821	HORIBA INSTRUMENTS INCORPORATED	Canton, MI, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1832216. Last updated year: 2026. Please use registration number 1832216 when referencing this establishment in official correspondence.