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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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