I-Stat Corp.
Medical device manufacturer in East Windsor, NJ.
21510(k) clearances
0PMA approvals
0recalls
Device types
- JGS Electrode, Ion Specific, Sodium 4
- CHL Electrode Measurement, Blood-Gases (Pco2… 3
- KHP Acid, Lactic, Enzymatic Method 2
- JBP Activated Whole Blood Clotting Time 2
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- JJR Electrolyte Controls (Assayed And Unassayed) 1
- JFP Electrode, Ion Specific, Calcium 1
- CGL Electrode, Ion Based, Enzymatic, Creatinine 1
- CGA Glucose Oxidase, Glucose 1
- GJS Test, Time, Prothrombin 1
- MMI Immunoassay Method, Troponin Subunit 1
- JJX Single (Specified) Analyte Controls… 1
- MYT Biosensor, Immunoassay, Cpk Or Isoenzymes 1
- NBC Test, Natriuretic Peptide 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K053597 | I-Stat B-Type Natriuretic Peptide (BNP)NBC · Traditional | 07/21/2006SE |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge…JGS · Special | 01/13/2006SE |
| K051433 | I-Stat Creatine Kinase MB (Ck-Mb)MYT · Traditional | 12/15/2005SE |
| K031873 | I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration…JJX · Traditional | 10/07/2003SE |
| K023582 | I-Stat Kaolin Act TestJBP · Traditional | 09/08/2003SE |
| K031739 | I-Stat Cardiac Troponin (Ctni) TestMMI · Traditional | 09/02/2003SE |
| K020355 | I-Stat Prothrombin Time TestGJS · Traditional | 05/14/2002SE |
| K012478 | Modification to: I-Stat Portable Clinical AnalyzerCHL · Special | 08/20/2001SE |
| K011478 | I-Stat SystemKHP · Traditional | 07/02/2001SE |
| K001387 | I-Stat Portable Clinical Analyzer, Model 300CGA · Traditional | 10/05/2000SE |
| K001154 | I-Stat Model 200 Portable Clinical AnalyzerJGS · Special | 04/18/2000SE |
| K992571 | I-Stat SystemJBP · Traditional | 02/10/2000SE |
| K982071 | I-Stat Lactate TestKHP · Traditional | 06/29/1998SE |
| K973292 | I-Stat SystemCGL · Traditional | 10/20/1997SE |
| K940918 | I-Stat 200 Portable Clinical AnalyzerCHL · Traditional | 05/10/1994SE |
| K936081 | I-Stat Tests for Acid-Base ParametersCHL · Traditional | 02/24/1994SE |
| K934642 | I-Stat Ionized Calcium TestJFP · Traditional | 12/17/1993SE |
| K934641 | I-Stat Control Levels 1,2,3JJR · Traditional | 12/09/1993SE |
| K921477 | I-Stat(Tm) Levels 1,2,3 ControlsJJY · Traditional | 11/02/1992SE |
| K912387 | I-Stat Model 100 Port Clin Analyzer & Test PackJGS · Traditional | 07/01/1991SE |
| K894914 | Model 100 Portable Clinical Analyzer and Test PackJGS · Traditional | 10/16/1989SE |