Medical Device Manufacturer · US , Princeton , NJ

I-Stat Corp. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1989

14

Total

14

Cleared

0

Denied

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

13 devices

1-12 of 13

Cleared Aug 20, 2001

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

Chemistry · 18d

Cleared Jul 02, 2001

Chemistry · 49d

Cleared Oct 05, 2000

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300

Chemistry · 156d

Cleared Apr 18, 2000

I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

Chemistry · 8d

Cleared Jun 29, 1998

I-STAT LACTATE TEST

Chemistry · 17d

Cleared Oct 20, 1997

Chemistry · 48d

Cleared May 10, 1994

I-STAT 200 PORTABLE CLINICAL ANALYZER

Chemistry · 74d

Cleared Feb 24, 1994

I-STAT TESTS FOR ACID-BASE PARAMETERS

Chemistry · 65d

Cleared Dec 17, 1993

I-STAT IONIZED CALCIUM TEST

Chemistry · 87d

Cleared Dec 09, 1993

I-STAT CONTROL LEVELS 1,2,3

Chemistry · 79d

Cleared Nov 02, 1992

I-STAT(TM) LEVELS 1,2,3 CONTROLS

Chemistry · 217d

Cleared Jul 01, 1991

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK

Chemistry · 61d