i-STAT PT/INR Cartridge

Reg #: 2245578 · FEI: 2245578 · Expires 2025

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: ABBOTT POINT OF CARE INC.
Registration Number: 2245578
FEI Number: 2245578
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 400 College Road East
City: Princeton
State: NJ
ZIP: 08540
Country: US

Regulatory Submissions

510(k) Number: K103195

Owner / Operator

Firm Name: ABBOTT LABORATORIES
Operator Number: 1415939
Address: 100 ABBOTT PARK RD., D-03Q3, AP52-1
City: Abbott Park
State: IL
Postal Code: 60064
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	Class 2	Clinical Chemistry	No	2012-01-17
Electrode, Ion Specific, Urea Nitrogen	CDS	Class 2	Clinical Chemistry	No	2012-01-17
Device, Hematocrit Measuring	JPI	Class 2	Hematology	No	2012-01-17
Biosensor, Immunoassay, Cpk Or Isoenzymes	MYT	Class 2	Clinical Chemistry	No	2012-01-17
Electrode, Ion Based, Enzymatic, Creatinine	CGL	Class 2	Clinical Chemistry	No	2012-01-17
Electrode, Ion Specific, Calcium	JFP	Class 2	Clinical Chemistry	No	2012-01-17
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2012-01-17
Test, Time, Prothrombin	GJS	Class 2	Hematology	No	2012-01-17
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2012-01-17
Activated Whole Blood Clotting Time	JBP	Class 2	Hematology	No	2012-01-17
Test, Natriuretic Peptide	NBC	Class 2	Clinical Chemistry	No	2012-01-17
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2012-01-17
Immunoassay Method, Troponin Subunit	MMI	Class 2	Clinical Chemistry	No	2012-01-17
Ph Rate Measurement, Carbon-Dioxide	JFL	Class 2	Clinical Chemistry	No	2012-01-17
Acid, Lactic, Enzymatic Method	KHP	Class 1	Clinical Chemistry	No	2012-01-17
Electrode, Ion-Specific, Chloride	CGZ	Class 2	Clinical Chemistry	No	2012-01-17

Proprietary Names

i-STAT PT/INR Cartridge i-STAT EG7+ Cartridge i-STAT G Cartridge i-STAT E3+ Cartridge i-STAT Kaolin ACT Cartridge i-STAT 6+ Cartridge i-STAT CG8+ Cartridge i-STAT EC8+ Cartridge i-STAT Celite ACT Cartridge i-STAT G3+ Cartridge i-STAT CREA Cartridge i-STAT CG4+ Cartridge i-STAT CK-MB Cartridge i-STAT CHEM8+ Cartridge i-STAT EG6+ Cartridge i-STAT cTnI Cartridge i-STAT BNP Cartridge i-STAT EC4+ Cartridge i-STAT Wireless Analyzer (Model 300W)

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device