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FDA 510(k) Applications Submitted by I-STAT CORPORATION
FDA 510(k) Number
Submission Date
Device Name
Applicant
K031739
06/04/2003
I-STAT CARDIAC TROPONIN (CTNI) TEST
I-STAT CORPORATION
K031873
06/17/2003
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
I-STAT CORPORATION
K020355
02/04/2002
I-STAT PROTHROMBIN TIME TEST
I-STAT CORPORATION
K023582
10/24/2002
I-STAT KAOLIN ACT TEST
I-STAT CORPORATION
K053110
11/04/2005
I-STAT CHEM8 + CARTRIDGE
I-STAT CORPORATION
K051433
06/01/2005
I-STAT CREATINE KINASE MB (CK-MB)
I-STAT CORPORATION
K053597
12/23/2005
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
I-STAT CORPORATION
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