Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005643513

FEI Number

3005643513

Entity Name

ABBOTT POINT OF CARE CANADA LIMITED

City/State/Country

Ottawa Ontario, CA

Establishment Address

185 CORKSTOWN ROAD, Ottawa Ontario K2H 8V4, CA

Establishment Type(s)

Manufacture Medical Device

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

K201778

PMA Number

N/A

All Registered Proprietary Names

iSTAT b-hCG Calibration Verification Controls Level 1, 2 & 3 iSTAT b-hCG Controls Level 1, 2 & 3 i-STAT TriControls Control i-STAT CG8+ cartridge, i-STAT 1 analyzer 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 CG8+ cartridge, i-STAT 1 analyzer i-STAT CREA Cartridge I-STAT CREATININE TEST Alinity c Proteins Control Kit (LN 08P6712) Alinity i STAT Myoglobin Controls (LN 04V3710) Alinity i Anti-CCP Controls (LN 09P2710) Alinity c CRP Vario HS Control Kit (LN 07P5612) i-STAT TBI Calibration Verification Alinity i STAT CK-MB Controls (LN 04V3810) i-STAT TBI Controls i-STAT hs-TnI Control Level 2 i-STAT hs-TnI Control Level 3 i-STAT hs-TnI Control Level 1 i-STAT hs-TnI Calibration Verification Levels 1-3 i-STAT® Total ?-hCG Test i-STAT CHEM8+ cartridge with the i-STAT 1 System 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 E3+ Cartridge i-STAT 6+ Cartridge i-STAT EC4+ Cartridge i-STAT CG8+ cartridge, i-STAT 1 analyzer i-STAT CG8+ cartridge, i-STAT 1 analyzer i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT CG4+ Cartridge with the i-STAT 1 System 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 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 Alinity Instrument (Model AN-500) i-STAT Sodium Test i-STAT 1 analyzer i-STAT hs-TnI cartridge i-STAT PT/INR Cartridge I-STAT PROTHROMBIN TIME TEST I-STAT CK-MB TEST i-STAT CK-MB Cartridge i-STAT Creatine Kinase MB Test i-STAT Troponin I Test i-STAT cTnI Cartridge i-STAT ACT Controls i-STAT PT Controls i-STAT PH Test i-STAT EG6+ Cartridge i-STAT G3+ Cartridge i-STAT PCO2 Test i-STAT PO2 Test i-STAT CG8+ Cartridge i-STAT EG7+ Cartridge i-STAT Sodium Test i-STAT CG4+ Cartridge i-STAT Potassium Test i-STAT EC8+ Cartridge i-STAT Troponin I Test i-STAT cTnI Cartridge i-STAT CHEM8+ cartridge with the i-STAT 1 System i-STAT G3+ cartridge i-STAT Lactate Test i-STAT CG4+ Cartridge i-STAT Controls i-STAT CHEM8+ Calibration Verificat i-STAT CHEM8+ Controls i-STAT Calibration Verification Set i-STAT TriControls Control I-STAT TC02 TEST i-STAT CHEM8+ Cartridge ION SPECIFIC I-STAT TCO2 TEST i-STAT TBI Plasma Cartridge with the i-STAT Alinity System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-11-19
JJR	Electrolyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-04-05
GLK	Control, Hematocrit	Hematology	Class 2	864.8625	2017-04-05
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
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
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
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2006-06-07
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-11-13
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2015-04-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-04-21
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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-11-13
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2006-04-10
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2025-08-28
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
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
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2020-03-03
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2020-04-10
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2020-04-10
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2023-11-16
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2024-05-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2016-07-12
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2025-01-30
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-01-30
GJS	Test, Time, Prothrombin	Hematology	Class 2	864.7750	2006-06-30
MYT	Biosensor, Immunoassay, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-06-27
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-06-27
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2013-11-13
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2006-03-23
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2006-03-23
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-06-27
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2020-02-21
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2023-11-16
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2006-05-12
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-17
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2006-06-30
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2006-06-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2006-06-30
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2006-06-30
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2006-06-30
CGL	Electrode, Ion Based, Enzymatic, Creatinine	Clinical Chemistry	Class 2	862.1225	2006-06-30
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2006-06-30
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2006-06-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2006-06-30
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2021-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

Jose Colon Business: Abbott Point of Care Email: jose.colon@abbott.com Phone: (609) 4549356

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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0139-2011	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Z-0778-2007	Instrumentation Laboratory Co.	2	GEM Premier 4000 Laboratory Analyzer

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005643513. Last updated year: 2026. Please use registration number 3005643513 when referencing this establishment in official correspondence.