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I-Stat Corporation

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K053597	I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)	NBC	2006-07-21	View
510(k)	K053110	Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge	JGS	2006-01-13	View
510(k)	K051433	I-STAT CREATINE KINASE MB (CK-MB)	MYT	2005-12-15	View
510(k)	K031873	I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET	JJX	2003-10-07	View
510(k)	K023582	I-STAT KAOLIN ACT TEST	JBP	2003-09-08	View
510(k)	K031739	I-STAT CARDIAC TROPONIN (CTNI) TEST	MMI	2003-09-02	View
510(k)	K020355	I-STAT PROTHROMBIN TIME TEST	GJS	2002-05-14	View

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