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I-Stat Corp.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K012478 MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZERCHL2001-08-20 View
510(k) K011478 I-STAT SYSTEMKHP2001-07-02 View
510(k) K001387 I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300CGA2000-10-05 View
510(k) K001154 I-STAT MODEL 200 PORTABLE CLINICAL ANALYZERJGS2000-04-18 View
510(k) K992571 I-STAT SYSTEMJBP2000-02-10 View
510(k) K982071 I-STAT LACTATE TESTKHP1998-06-29 View
510(k) K973292 I-STAT SYSTEMCGL1997-10-20 View
510(k) K940918 I-STAT 200 PORTABLE CLINICAL ANALYZERCHL1994-05-10 View
510(k) K936081 I-STAT TESTS FOR ACID-BASE PARAMETERSCHL1994-02-24 View
510(k) K934642 I-STAT IONIZED CALCIUM TESTJFP1993-12-17 View
510(k) K934641 I-STAT CONTROL LEVELS 1,2,3JJR1993-12-09 View
510(k) K921477 I-STAT(TM) LEVELS 1,2,3 CONTROLSJJY1992-11-02 View
510(k) K912387 I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACKJGS1991-07-01 View
510(k) K894914 MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACKJGS1989-10-16 View
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