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

I-Stat Corporation has 7 FDA 510(k) cleared medical devices. Based in East Windsor, US.

Historical record: 7 cleared submissions from 2002 to 2006. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by I-Stat Corporation Filter by specialty or product code using the sidebar.

I-Stat Corporation is one of 22884 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

7 devices

1-7 of 7

Cleared Jul 21, 2006

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)

Chemistry · 210d

Cleared Jan 13, 2006

Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+...

Chemistry · 70d

Cleared Dec 15, 2005

I-STAT CREATINE KINASE MB (CK-MB)

Chemistry · 197d

Cleared Oct 07, 2003

I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3

Chemistry · 112d

Cleared Sep 08, 2003

I-STAT KAOLIN ACT TEST

Hematology · 319d

Cleared Sep 02, 2003

I-STAT CARDIAC TROPONIN (CTNI) TEST

Chemistry · 90d

Cleared May 14, 2002

I-STAT PROTHROMBIN TIME TEST

Hematology · 99d