Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016438761

FEI Number

3016438761

Entity Name

ABBOTT LABORATORIES

City/State/Country

Irving, TX, US

Establishment Address

1915 Hurd Drive, Irving, TX 75038, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACID PHOSPHATASE (ACP) (LN 9D87-21) CARBON DIOXIDE (LN 3L80-21, 3L80-31, 3L80-22, 3L80-32, 3L80-42) Alinity c Carbon Dioxide Reagent Kit (LN 07P7220, 07P7230) Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131) Alinity i System Accessories Alinity i System Alinity i Refurbished Processing Module (LN 03R65-84) Immunoglobulin G (IgG) (LN 9D99-21, 9D99-22) Aliniity c Immunoglobulin G Reagent Kit (LN 09P6220) Immunoglobulin G (IgG) (Alinity c, LN 09P6224) Immunoglobulin G (IgG) (ARCHITECT, LN 09D9924) ALBUMIN BCP (LN 7D54-21) Alinity c Albumin BCP Reagent Kit (LN 08P0320) Alinity h-series Slide Label Cartridge (LN 09P8201) Alinity h-series Smear Tape Cartridge (LN 09P8301) CELL-DYN 18 Plus Control (LN 07V07-06, 07V07-12) CELL-DYN 22 Plus Control (LN 07V09-06, 07V09-12) GLUCOSE (LN 3L82-21, 3L82-41, 3L82-22, 3L82-42) CELL-DYN Emerald Cleaner (LN 09H46-02) CELL-DYN Emerald 22 Easy Cleaner (LN 09H60-03) CELL-DYN Enzymatic Cleaner Concentrate (LN 99644-01) URINE/CSF PROTEIN (UPro) (LN 7D79-21, 7D79-31, 7D79-22, 7D79-32) Alinity c Urine/CSF Protein Reagent Kit (LN 07P5920, 07P5930) MAGNESIUM (LN 7D70-21, 7D70-31) ACTIVATED ASPARTATE AMINOTRANSFERASE (LN 8L91-21, 8L91-41) Urine/CSF Protein Calibrator (LN 1E71-02) Iron/Magnesium Calibrator (LN 1E69-03) Bilirubin Calibrator (LN 1E66-04) Lipase Calibrator (LN 3E16-02) Carbon Dioxide Calibrator (LN 1E64-02) CELL-DYN Diluent/Sheath (LN 01H73-01) CELL-DYN Emerald 22 Diluent (LN 09H62-01) CELL-DYN Emerald Diluent (LN 09H48-02) Alinity h-series Diluent (LN 04R2601) Complement C4 (LN 9D97-21, 9D97-22) Alinity c Complement C4 Reagent Kit (LN 09P5720) Complement C4 (Alinity c, LN 09P5724) Complement C4 (ARCHITECT, LN 09D9724) MULTICONSTITUENT CALIBRATOR (LN 1E65-05) TDM Multiconstituent Calibrator (LN 5P04-01) ASPARTATE AMINO TRANSFERASE (AST) (LN 7D81-21) Alinity c Phosphorus Reagent Kit (LN 08P4020, 08P4030) Phosphorus2 (Alinity c, LN 04U0320, 04U0330) Phosphorus2 (ARCHITECT, LN 04T0720, 04T0730) TRIGLYCERIDE (7D74-21, 7D74-22) Immunoglobulin A (IgA) (LN 9D98-21, 9D98-22) Specific Proteins Multiconstituent Calibrator (LN 1E78-02) Alinity c Immunoglobulin A Reagent Kit (LN 09P6120) Immunoglobulin A (IgA) (Alinity c, LN 09P6124) Immunoglobulin A (IgA) (ARCHITECT, LN 09D9824) LACTATE DEHYDROGENASE (LDH) (LN 2P56-21, 2P56-22, 2P56-42) Alinity c Lactate Dehydrogenase Reagent Kit (LN 07P7420, 07P7430) Lactate Dehydrogenase2 (LN 04T0320, 04T0330, 04T9920, 04T9930) Accelerator APS Alinity c Ultra HDL Reagent Kit (LN 07P7520, 07P7530) ULTRA HDL (LN 3K33-21, 3K33-22) Alinity c Calcium Reagent Kit (LN 07P5720, 07P5730) CALCIUM (LN 3L79-21, 3L79-31, 3L79-22, 3L79-32, 3L79-42) Alinity s System Accessories Alinity s System Magnesium (LN 3P68-22, 3P68-32) Alinity c Magnesium Reagent Kit (LN 08P1920, 08P1930) Magnesium (Alinity c; LN 08P1925, 08P1934) Magnesium (ARCHITECT; LN 03P6824, 03P6834) LIPID MULTICONSTITUENT CALIBRATOR (LN 5P56-01) CREATININE (LN 3L81-22, 3L81-32, 3L81-23, 3L81-33) Alinity c Creatinine Reagent Kit (LN 07P9920, 07P9930) Alinity i System Alinity c System Alinity i Refurbished Processing Module (LN 03R65-84) CELL-DYN 29 Plus Control (w/Retics) (LN 08H58-01, 08H58-02) Alinity h-series Control 29P (LNs 04U7206, 04U7212, 06V87-06, 06V87-12) GAMMA-GLUTAMYL TRANSFERASE (GGT) (LN 7D65-21, 7D65-22, 7D65-42) Alinity c Gamma-Glutamyl Transferase Reagent Kit (LN 07P7320, 07P7330) Gamma-Glutamyl Transferase2 (ARCHITECT; LN 04T0020, 04T0030) Gamma-Glutamyl Transferase2 (Alinity c; LN 04T9620, 04T9630) Lipase2 Calibrator (LN 04U0001, 04T0401) LIPASE (LN 7D80-31) Lipase2 (LN 04T0420, 04U0020) Alinity c System Alinity ci-series System Control Module (LN 03R7001) Alinity c Processing Module (LN 03R6701) Alinity c System Accessories Alinity c Glucose Reagent Kit (LN 07P5520, 07P5530) ALKALINE PHOSPHATASE (LN 7D55-21, 7D55-22, 7D55-31, 7D55-32) Alinity c Alkaline Phosphatase Reagent Kit (LN 08P2020, 08P2030) DIRECT BILIRUBIN (LN 8G63-21, 8G63-22) Alinity c Direct Bilirubin Reagent Kit (LN 07P9720) ARCHITECT System Accessories ARCHITECT System Alinity c Aspartate Aminotransferase Reagent Kit (LN 08P1720) Alinity c Activated Apartate Aminotransferase Reagent Kit (LN 08P2320) Activated Aspartate Aminotransferase (LN 8L91-22, 8L91-42) Aspartate Aminotranserase (LN 7D81-22) Aspartate Aminotransferase2 (ARCHITECT; LN 04S9020, 04S9030) Activated Aspartate Aminotransferase (ARCHITECT, LN 08L9124, 08L9144) Activated Aspartate Aminotransferase (A-AST) (Alinity c, LN 08P2324) Aspartate Aminotransferase2 (Alinity c; LN 04T8620,04T8630) TOTAL BILIRUBIN (LN 6L45-21, 6L45-41, 6L45-22, 6L45-42) Alinity c Total Bilirubin Reagent Kit (LN 04V5121, 04V5131) Total Bilirubin (LN 7P32-21, 7P32-41) CELL-DYN EMERALD (LN 09H39-01) Alinity h-series Phosphate Buffer (LN 07P8301) ALANINE AMINOTRANSFERASE (ALT) (LN 7D56-21, 7D56-22) ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42) Alinity c Alanine Aminotransferase Reagent Kit (LN 07P9820) Alinity c Activated Alanine Aminotransferase Reagent Kit (LN 08P1820) Alanine Aminotransferase2 (Alinity c; LN 04T8420, 04T8430) Activated Alanine Aminotransferase (A-ALT) (Alinity c, LN 08P1824) Alanine Aminotransferase2 (ARCHITECT; LN 04S8820, 04S8830) Activated Alanine Aminotransferase (ARCHITECT, LN 08L9224, 08L9244) Cystatin C Calibrators (LN 06T3201) Alinity i Syphilis TP Calibrator (LN 07P6001) Alinity i Progesterone Calibrators (LN 08P3601) Alinity i 25-OH Vitamin D Calibrators (LN 08P4501) Alinity i Total T4 Calibrators (LN 07P9501) Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801) Alinity i FSH Calibrators (LN 07P4901) Alinity i Free T4 Calibrators (LN 07P7001) Alinity i B12 Calibrators (LN 07P6702) Alinity c UIBC Calibrator Kit (LN 08P4401) Alinity i Prolactin Calibrators (LN 07P6601) Alinity i Total B-hCG Calibrators (LN 07P5101) Alinity i TSH Calibrators (LN 07P4801) Alinity c Hemoglobin A1c Calibrators (LN 08P4301) Alinity i C-Peptide Calibrators (LN 09P3601) Alinity i Ferritin Calibrators (LN 07P6501) Alinity i Intact PTH Calibrators (LN 08P3102) Alinity i Estradiol Calibrators (LN 07P5001) Lipase NG OC Calibrator (LN 04Y8501) Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601) Alinity i LH Calibrators (LN 07P9101) Alinity i Anti-TPO Calibrators (LN 09P3501) Alinity i T-Uptake Calibrators (LN 08P1201) Alinity i Folate Calibrators (LN 08P1402) Alinity c B2-Microglobulin Calibrator (LN 01R0902) Alinity i Insulin Calibrators (LN 04T7501) Alinity c Prealbumin Calibrator Kit (LN 04S0101) Alinity i CA 15-3 Calibrators (LN 08P5101) Alinity i Anti-Tg Calibrators (LN 09P3401) Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002) Alinity i Cortisol Calibrators (LN 08P3301) Alinity c Lp(a) Calibrators (LN 01R1401) Alinity i CA 125 II Calibrators (LN 08P4901) Alinity i DHEA-S Calibrators (LN 09P3701) Alinity i Homocysteine Calibrators (LN 09P2801) Alinity c ASO Calibrator (LN 01R0602) Alinity i Total T3 Calibrators (LN 07P9401) ARCHITECT Insulin Calibrators (LN 08K4103) Alinity i HE4 Calibrators (LN 08P5001) Alinity i CA 19-9XR Calibrators (LN 08P3201) ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01) ARCHITECT Total T3 Calibrators (LN 7K64-02) Alinity i Free T3 Calibrators (LN 07P6901) Alinity i Tacrolimus Calibrators (LN 09P4201) Prealbumin Calibrator (LN 6E57-03) Alinity i Sirolimus Calibrators (LN 09P4101) Alinity i STAT High Sensitivity Troponin-I Calibrators (LN 04Z2101) Acetaminophen Calibrator (LN 03R7401) Acetaminophen Calibrator (Alinity c, LN 07P5401) UCH-L1 Calibrators (Alinity i, LN 04W1901) GFAP Calibrators (ARCHITECT, LN 4W16-01) Alinity i BRAHMS PCT Calibrators (LN 01R1801) GFAP Calibrators (Alinity i, LN 04W1701) Alere NT-proBNP for Alinity i Calibrators (LN 04S7902) ACE Calibrator (LN 06U8601) UCH-L1 Calibrators (ARCHITECT, LN 4W18-01) ACE Calibrator (LN 06U8201) Alinity i CMV IgG Calibrators (LN 07P4202) DAPI I Counterstain (1000 ng/mL) 500 ?L x 2 Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (100 mL) Enzyme Conjugate Diluent 2.5X DF with Low Sodium Bisulfite GPR (600 mL) Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (40 mL) CGH Target Slides Higher pH Antibody Diluent DF 2X NAD and G6P GPR (100 mL) VP 2000 Pretreatment Reagent (500 mL) Lower pH Enzyme Conjugate Diluent DF GPR (600 mL) Enzyme Conjugate Diluent DF GPR (700 mL) Alcohol Diluent GPR 60 mL VYSIS Paraffin Pretreatment Reagent KIT Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (400 mL) Higher pH Antibody Diluent DF 2X NAD and G6P GPR (1000 mL) VP 2000 Protease I (250 mg x 2) NICK Translation Kit Abbott Proteinase K SpectrumGreen Male Reference DNA Paraffin Pretreatment Kit III Protease Buffer II Gold dUTP rTth Polymerase DNA Activation Reagent SpectrumRed Female Reference DNA CEP Hybridization Buffer VP 2000 Protease Buffer (500 mL) SpectrumGreen Female Reference DNA AMP Check E GPR Master Mix E GPR ProbeChek MultiVysion Control Slides Abbott Bisulfite Modification Kit Vysis IntelliFish FFPE Tissue Pretreatment Protease (for 50mL) Vysis IntelliFish Universal FFPE Tissue Pretreatment and Wash Vysis IntelliFish Hybridization Buffer 1x250 uL Vysis IntelliFish FFPE Tissue Pretreatment Protease (for 500mL) Vysis IntelliFish Hybridization Buffer 5x250 uL Abbott mSample Preparation System Bulk mLysis DNA Buffer Alinity h-series AutoClean Solution (LN 01R5104) DAPI II Counterstain (125 ng/mL) VP 2000 Reagents ? Protease II (750 mg) 750 mg Orange dUTP Aqua dUTP 20X SSC, 500g RNA AMP Check VYSIS PARAFFIN PRETREATMENT KIT I SpectrumRed Male Reference DNA CGH NICK Translation Reagent Set VP 2000 Reagents ? 2N MgCl 2 (120 mL) DAPI III Counterstain (42 ng/mL) 500 ?L x 2 LSI®/WCP® Hybridization Buffer Hemo-De Solvent CGH NICK TRANSLATION REAGENTSET DNA AMP Check CGH Hybridization Reagent Kit Assembly Human Cot-1 DNA, 250 uL For Laboratory Use RNA Activation Reagent SpectrumGreen CGH Control DNA (MPE 600) NP-40 1000µL x 2 Red dUTP Antibody Diluent DF 2X NAD and G6P GPR (1000 mL) Enzyme Conjugate Diluent DF GPR (70 mL) Antibody Diluent DF with Low NAD & G6P 2X NAD & G6P GPR (1000 Ml) HEIA Enzyme Conjugate Diluent DF GPR (100 mL) HEIA Enzyme Conjugate Diluent DF GPR (1000 mL) HEIA Enzyme Conjugate Diluent DF GPR (100 mL) Green dUTP LSI®/WCP® Hybridization Buffer 2 x 500 ?L, For Laboratory Use Lower pH Enzyme Conjugate Diluent DF GPR (60 mL) Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (60 mL) Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (100 mL) Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (1000 mL) Antifade II Solution 60 ?L x 2 Taq Gold Polymerases Pretreatment Reagent 500 mL Enzyme Conjugate Diluent DF GPR (600 mL) Propidium Iodide Counterstain CGH Control DNA (MPE 600) Unlabeled Enzyme Conjugate Diluent DF GPR (60 mL) Paraffin Pretreatment Kit II FISH Specimen Pretreatment Reagent Kit Antifade Solution, 2 x 240 µL For Laboratory Use Antifade II Solution, 2 x 60 uL, For Laboratory Use VP 2000 Reagents ? 20X SSC (500 g) Antibody Diluent DF 2X NAD and G6P GPR (100 mL) VYSIS FISH Specimen Pretreatment Reagent Kit Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (1000 mL) CHOLESTEROL (LN 7D62-21, 7D62-22) Alinity c Cholesterol Reagent Kit (LN 07P7620) Alinity h-series May-Grunwald-Giemsa Stain (LN 08P8101) Alinity h-series Wright-Giemsa Stain (LN 08P8001) Alinity h-series Smear Fix (LN 08P7901) Alinity c Clinical Chemistry Calibrator Kit (LN 08P6503) Alinity c Carbon Dioxide Calibrator Kit (LN 08P7201) Alinity c Multiconstituent Calibrator Kit (LN 08P6001) Alinity c ICT Urine Calibrator Kit (LN 08P7001) ICT Urine Calibrator (LN 1E47-03) Alinity c Plasmaproteins Cal 3x Kit (LN 08P6601) Alinity c ICT Serum Calibrator Kit (LN 08P6901) Alinity c Proteins Calibrators (LN 08P6702) ICT Serum Calibrator (LN 1E46-04) Alinity i Anti-CCP Calibrators (LN 09P2701) Alinity c Lipid Multiconstituent Calibrator Kit (LN 09P1403) Alinity c Specific Proteins Multiconstituent Calibrator Kit (LN 08P6201) Alinity c Bilirubin Calibrator Kit (LN 08P6101) Alinity c Urine/CSF Protein Calibrator Kit (LN 08P7101) Alinity c Iron Calibrator Kit (LN 04U7501) Bilirubin Calibrator (LN 1E66-05) Urine/CSF Protein Calibrator (LN 1E71-03) Carbon Dioxide Calibrator (LN 1E64-03) Specific Proteins Multiconstituent Calibrator (LN 1E78-04) Multiconstituent Calibrator (LN 1E65-06) Lipid Multiconstituent Calibrator (LN 5P56-02) Consolidated Chemistry Calibrator (ARCHITECT; LN 04V1501) Consolidated Chemistry Calibrator (Alinity c; LN 04V6201) ICT (Sodium, Potassium, Chloride) Alinity c Apolipoprotein B Reagent Kit (LN 09P4720) Apolipoprotein B (Alinity c, LN 09P4724) Apolipoprotein B (ARCHITECT, LN 09D9324) APOLIPOPROTEIN B (APOB) (LN 9D93-21, 9D93-22) PREALBUMIN (LN 1E02-21, 1E02-22, 01E0224) Prealbumin Calibrator (LN 6E57-02) Alinity c Prealbumin Reagent Kit (LN 09P8620) Prealbumin (Alinity c, LN 09P8624) Alinity h-series Water Purification System (LN 09P7101) Hemoglobin A1c (LN 4P52-20, 4P52-22) Hemoglobin A1c Controls (LN 4P52-11) Hemoglobin A1c Calibrators (LN 4P52-01) Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320, 08P4321) CELL-DYN WBC Reagent - Part B (LN 01H78-01/01H78-02) CELL-DYN CN-Free HGB Reagent (LN 01H79-01) CELL-DYN CN Free HGB/NOC Lyse (LN 03H80-02) CELL-DYN WBC Lyse (LN 08H52-01) CELL-DYN Emerald CN-Free Lyse (LN 09H47-02) CELL-DYN Emerald 22 Lyse (LN 09H6101) Alinity h-series HGB Reagent (LN 07P8104) CELL-DYN WBC Reagent - Part A (LN 01H77-01/01H77-02)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CKB	Acid Phosphatase, Naphthyl Phosphate	Clinical Chemistry	Class 2	862.1020	2007-12-07
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-12-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-05-03
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2018-05-03
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-07
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2007-12-07
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	1999-01-12
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2025-07-29
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-12-07
JCB	Detergent	Pathology	Class 1	864.4010	2000-12-26
JGQ	Turbidimetric, Total Protein	Clinical Chemistry	Class 2	862.1635	2007-12-07
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2007-12-07
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2014-01-16
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-19
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2000-12-26
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-07
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-01-16
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2007-12-07
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2018-06-02
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2000-04-24
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-07
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	1999-01-12
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-12-18
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-12-18
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-12-18
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-12-18
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2012-12-18
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2007-12-10
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2007-12-07
MZA	Test, Equipment, Automated Bloodborne Pathogen	Unknown	Class N	N/A	2016-12-15
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2018-12-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-01-16
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-01-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-01-06
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2022-01-06
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2016-03-01
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-01-06
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2024-06-05
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2024-06-05
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2024-06-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2024-06-05
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2024-06-05
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2024-06-05
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2020-01-10
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2000-12-26
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2003-08-04
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-05-03
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-05-03
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2011-10-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2007-12-07
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	1977-12-13
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2018-05-14
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2014-01-16
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2014-01-16
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2016-11-07
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2016-11-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-01-14
JCC	Ph Buffer	Pathology	Class 1	864.4010	2023-09-27
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2000-12-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-05-03
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1998-06-30
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2007-12-07
GJL	Romanowsky Stains	Hematology	Class 1	864.1850	2023-09-28
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2023-09-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-11-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-12-19
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-12-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2007-12-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-12-19
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2007-12-07
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	1999-01-13
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2023-09-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-07-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-07-09
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2015-07-09
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2015-07-09
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	1994-09-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

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

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K880678	Ventrex Laboratories, Inc.	MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY	1988-04-05
K072500	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE/SERUM TEST	2009-04-21
K761345	J.T. Baker Chemical Co.	GLUCO-HEX TM REAGENT KIT	1977-01-05
K771464	Instrumentation Laboratory CO	MULTISTAT III GLUCOSE TEST	1977-09-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
3006198300	Diamond Diagnostics Inc.	Budapest, HU
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
3004493545	RANDOX LABORATORIES LIMITED	CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
3021841051	BIALEX LAB	Wichita Falls, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016438761. Last updated year: 2026. Please use registration number 3016438761 when referencing this establishment in official correspondence.