Biomerieux Vitek, Inc.

FDA 510(k) & PMA Approved Devices — 49 products

Total Devices49

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K973819	VIDAS D-DIMER (DD) ASSAY	DAP	1998-03-10	View
510(k)	K972895	VIDAS ROTAVIRUS (RTV) ASSAY	LIQ	1997-10-03	View
510(k)	K965092	VIDAS ROTAVIRUS ASSAY	LIQ	1997-05-05	View
510(k)	K964887	VIDAS C. DIFFICILE TOXIN A II ASSAY	LLH	1997-04-08	View
510(k)	K955627	VIDAS CHLAMYDIA BLOCKING ASSAY	LJC	1996-10-07	View
510(k)	K962609	GRAM NEGATIVE IDENTIFICATION PLUS CARD	LRH	1996-08-30	View
510(k)	K962549	VIDAS CREATINE KINASE MB ASSAY 30-421	JHX	1996-08-30	View
510(k)	K952095	VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)	LQL	1996-03-12	View
510(k)	K955647	VIDAS ESTRADIOL II (E2II) ASSAY	CHP	1996-02-06	View
510(k)	K943812	VIDAS LYME SCREEN II	LSR	1995-06-13	View
510(k)	K942050	HEMOLAB COFAC IX	GJT	1995-05-19	View
510(k)	K942049	BIOMERIEUX HEMOLAB COFAC II	GJT	1995-05-19	View
510(k)	K935851	BIOMERIEUX HEMOLAB COFAC X	GJT	1995-01-17	View
510(k)	K935850	BIOMERIEUX HEMOLAB COFAC VII	GJT	1995-01-17	View
510(k)	K934210	HEMOLAB PROTEIN C CHROMOGENIC ASSAY	GGP	1994-12-22	View
510(k)	K931992	HEMOLAB	GKP	1994-12-22	View
510(k)	K934156	BIOMERIEUX HEMOLAB AT III	JBQ	1994-12-22	View
510(k)	K943811	ENZYME-LINKED FLUORESCENT IMMUNOASSAY	CFT	1994-11-02	View
510(k)	K933549	VIDAS CMV IGM ASSAY	LKQ	1994-08-02	View
510(k)	K934274	HEMOLAB HEPARICHROM ASSAY	KFF	1994-05-06	View