Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2245578

FEI Number

2245578

Entity Name

ABBOTT POINT OF CARE INC.

City/State/Country

Princeton, NJ, US

Establishment Address

400 College Road East, Princeton, NJ 08540, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

K183678

PMA Number

N/A

All Registered Proprietary Names

i-STAT BNP Controls i-STAT BNP Calibration Verification i-STAT CK-MB controls i-STAT CK-MB Calibration Verification Control Set i-STAT cTnI Calibration Verification 1-3 i-STAT cTnI Controls i-STAT CG8+ cartridge, i-STAT 1 analyzer i-STAT CG8+ cartridge, i-STAT 1 analyzer i-STAT 1 Analyzer (Models 300 & 300-G) i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT TBI Plasma Cartridge with the i-STAT Alinity System i-STAT TBI cartridge i-STAT TBI Calibration Verification Levels 1-3 i-STAT TBI Control Level 2 i-STAT TBI Control Level 1 i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT E3+ Cartridge i-STAT cTnI Cartridge i-STAT CG4+ Cartridge i-STAT EG7+ Cartridge i-STAT Celite ACT Cartridge i-STAT G3+ Cartridge i-STAT CHEM8+ Cartridge i-STAT CREA Cartridge i-STAT 6+ Cartridge i-STAT CG8+ Cartridge i-STAT CK-MB Cartridge i-STAT Kaolin ACT Cartridge i-STAT EC4+ Cartridge i-STAT EG6+ Cartridge i-STAT G Cartridge i-STAT PT/INR Cartridge i-STAT BNP Cartridge i-STAT EC8+ Cartridge i-STAT Wireless Analyzer (Model 300W) i-STAT PTplus Cartridge i-STAT PTplus Cartridge with i-STAT 1 System i-STAT PTplus Control Level 1 i-STAT PTplus Control Level 2 iSTAT b-hCG Calibration Verification Controls Level 1, 2 & 3 iSTAT b-hCG Controls Level 1, 2 & 3 i-STAT CG8+ cartridge, i-STAT 1 analyzer i-STAT CG8+ cartridge, i-STAT 1 analyzer i-STAT Alinity Instrument (Model AN-500) i-STAT Sodium Test i-STAT CHEM8+ cartridge with the i-STAT 1 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-11-13
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2025-08-28
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2025-08-28
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2025-09-02
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-09-02
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-12-17
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2020-02-18
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2020-02-18
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2020-02-18
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2020-02-18
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2021-01-27
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2024-05-08
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2020-02-21
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2021-08-25
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2021-08-25
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2021-08-25
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2021-08-25
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2021-08-25
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2021-08-25
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2021-08-25
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2021-08-25
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2021-08-25
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2020-02-21
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2012-01-17
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2012-01-17
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2012-01-17
MYT	Biosensor, Immunoassay, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2012-01-17
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-01-17
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2012-01-17
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2012-01-17
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-01-17
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-01-17
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2012-01-17
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2012-01-17
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2012-01-17
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-01-17
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2012-01-17
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2012-01-17
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-01-17
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2023-11-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-11-19
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2025-08-28
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2025-08-28
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2025-08-28
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2016-07-12
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2020-02-18
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2020-02-18

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.

View Entity Profile →

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
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
K884771	Instrumentation Laboratory CO	IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY	1989-02-10
K811074	Reagents Applications, Inc.	GLUCOSE REAGENT-ENZYMATIC-COLOR 500	1981-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2245578. Last updated year: 2026. Please use registration number 2245578 when referencing this establishment in official correspondence.