Medical Device Manufacturer · US , Princeton , NJ

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

14 submissions · 14 cleared · Since 1989

Total

Cleared

Denied

I-Stat Corp. has 14 FDA 510(k) cleared chemistry devices. Based in Princeton, US.

Historical record: 14 cleared submissions from 1989 to 2001.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

I-Stat Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

14 devices

1-14 of 14

Cleared Aug 20, 2001

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300

K001387 · CGA

Chemistry · 156d

Cleared Apr 18, 2000

I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

I-STAT 200 PORTABLE CLINICAL ANALYZER

K940918 · CHL

Chemistry · 74d

Cleared Feb 24, 1994

I-STAT TESTS FOR ACID-BASE PARAMETERS

K936081 · CHL

Chemistry · 65d

Cleared Dec 17, 1993

I-STAT IONIZED CALCIUM TEST

K934642 · JFP

Chemistry · 87d

Cleared Dec 09, 1993

I-STAT CONTROL LEVELS 1,2,3

K934641 · JJR

Chemistry · 79d

Cleared Nov 02, 1992

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

K921477 · JJY

Chemistry · 217d

Cleared Jul 01, 1991

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK

K912387 · JGS

Chemistry · 61d

Cleared Oct 16, 1989

MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK

K894914 · JGS

Chemistry · 75d

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

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

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