Bio/Data Corp.

FDA 510(k) & PMA Approved Devices — 37 products

Total Devices37

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K001891	MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C	GKP	2000-07-12	View
510(k)	K943153	MICROSAMPLE COAGULATION ANALYZER	GKP	1995-03-24	View
510(k)	K893650	PLATELET AGGREGATION PROFILER MODEL PAP-4C	JPA	1989-06-23	View
510(k)	K881150	KINETIC FIBRINOGEN ASSAY	GIS	1988-03-28	View
510(k)	K873382	PLATELET EXTRACT REAGENT	GGW	1987-11-20	View
510(k)	K860751	VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA	JPK	1986-03-18	View
510(k)	K860342	MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP	JPA	1986-03-04	View
510(k)	K854546	MICROSAMPLE COAGULATION ANALYSER MODEL 110P	JPA	1986-01-07	View
510(k)	K853897	CITREX H	GGW	1985-10-10	View
510(k)	K853246	CALCIUM CHLORIDE	JPA	1985-08-13	View
510(k)	K853076	CITREX I	JPA	1985-08-12	View
510(k)	K852195	CEPHALINEX ACTIVATED PTT REAGENT	GGW	1985-08-12	View
510(k)	K853078	CITREX III	JPA	1985-08-12	View
510(k)	K853077	CITREX II	JPA	1985-08-12	View
510(k)	K852484	PLASTINEX	GJS	1985-08-12	View
510(k)	K845000	THROMBINEX BOVINE THROMBIN	GJA	1985-03-26	View
510(k)	K843207	REPTILASE -PC	JCO	1984-10-23	View
510(k)	K834301	THROMBOLYTIC ACTIVITY TEST	GJA	1984-02-04	View
510(k)	K821005	PLATELET AGGREGATION PROFILER #PAP-4	JBX	1982-06-01	View
510(k)	K812108	LOW FIBRINOGEN CONTROL	KQJ	1981-09-24	View