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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