I-Stat Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012478MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZERAugust 20, 2001
K011478I-STAT SYSTEMJuly 2, 2001
K001387I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300October 5, 2000
K001154I-STAT MODEL 200 PORTABLE CLINICAL ANALYZERApril 18, 2000
K992571I-STAT SYSTEMFebruary 10, 2000
K982071I-STAT LACTATE TESTJune 29, 1998
K973292I-STAT SYSTEMOctober 20, 1997
K940918I-STAT 200 PORTABLE CLINICAL ANALYZERMay 10, 1994
K936081I-STAT TESTS FOR ACID-BASE PARAMETERSFebruary 24, 1994
K934642I-STAT IONIZED CALCIUM TESTDecember 17, 1993
K934641I-STAT CONTROL LEVELS 1,2,3December 9, 1993
K921477I-STAT(TM) LEVELS 1,2,3 CONTROLSNovember 2, 1992
K912387I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACKJuly 1, 1991
K894914MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACKOctober 16, 1989