FDA 510(k) Applications Submitted by I-STAT CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K973292 09/02/1997 I-STAT SYSTEM I-STAT CORP.
K001154 04/10/2000 I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER I-STAT CORP.
K001387 05/02/2000 I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-STAT CORP.
K011478 05/14/2001 I-STAT SYSTEM I-STAT CORP.
K992571 08/02/1999 I-STAT SYSTEM I-STAT CORP.
K012478 08/02/2001 MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER I-STAT CORP.
K982071 06/12/1998 I-STAT LACTATE TEST I-STAT CORP.


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