# I-Stat Corp.

- Location (FDA's records): East Windsor, NJ
- FDA decisions: 21 (1989–2006): 21 510(k) clearances
- Names in FDA's records: I-Stat Corp. (14); I-Stat Corporation (7)
- Product codes: JGS (4), CHL (3), KHP (2), JBP (2), CGL (1), JJY (1), MMI (1), CGA (1), MYT (1), JJX (1), NBC (1), JFP (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 18 (1 its own)
- Recalls linked to its devices: 69 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Epocal, Inc.: 6 (https://510kreport.com/company/epocal)
- Avl Scientific Corp.: 4 (https://510kreport.com/company/avl-scientific)
- Streck Laboratories, Inc.: 2 (https://510kreport.com/company/streck-laboratories)
- Abbott Point of Care, Inc.: 1 (https://510kreport.com/company/abbott-point-of-care)
- Philips Medizin Systeme Boblingen GmbH: 1 (https://510kreport.com/company/philips-medizin-systeme-boblingen)
- Abbott Pont of Care, Inc.: 1 (https://510kreport.com/company/abbott-pont-of-care)
- Abaxis, Inc.: 1 (https://510kreport.com/company/abaxis)
- Radiometer Medical Aps: 1 (https://510kreport.com/company/radiometer-medical)

## Its most-cited devices
- K001387: I-Stat Portable Clinical Analyzer, Model 300 (2000), cited by 6
- K940918: I-Stat 200 Portable Clinical Analyzer (1994), cited by 5
- K982071: I-Stat Lactate Test (1998), cited by 2
- K934641: I-Stat Control  Levels 1,2,3 (1993), cited by 2
- K973292: I-Stat System (1997), cited by 1
- K011478: I-Stat System (2001), cited by 1

## Recent decisions
- K053597: I-Stat B-Type Natriuretic Peptide (BNP) (Jul 21, 2006)
- K053110: Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge (Jan 13, 2006)
- K051433: I-Stat Creatine Kinase MB (CK-MB) (Dec 15, 2005)
- K031873: I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control Set (Oct 7, 2003)
- K023582: I-Stat Kaolin Act Test (Sep 8, 2003)
- K031739: I-Stat Cardiac Troponin (Ctni) Test (Sep 2, 2003)
- K020355: I-Stat Prothrombin Time Test (May 14, 2002)
- K012478: Modification to: I-Stat Portable Clinical Analyzer (Aug 20, 2001)

Source page: https://510kreport.com/company/i-stat