Medical Device Manufacturer · US , East Windsor , NJ

I-Stat Corporation - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2002

Recent clearances: I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP), 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, I-STAT CREATINE KINASE MB (CK-MB)

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - I-Stat Corporation Hematology ✕

2 devices

1-2 of 2

Cleared Sep 08, 2003

I-STAT KAOLIN ACT TEST

Hematology · 319d

Cleared May 14, 2002

I-STAT PROTHROMBIN TIME TEST

Hematology · 99d