Medical Device Manufacturer · US , East Windsor , NJ

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

7 submissions · 7 cleared · Since 2002

7

Total

7

Cleared

0

Denied

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

5 devices

1-5 of 5

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 02, 2003

I-STAT CARDIAC TROPONIN (CTNI) TEST

Chemistry · 90d