Bio/Data Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
37
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CJuly 12, 2000
K943153MICROSAMPLE COAGULATION ANALYZERMarch 24, 1995
K893650PLATELET AGGREGATION PROFILER MODEL PAP-4CJune 23, 1989
K881150KINETIC FIBRINOGEN ASSAYMarch 28, 1988
K873382PLATELET EXTRACT REAGENTNovember 20, 1987
K860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMAMarch 18, 1986
K860342MICROSAMPLE COAGULATION ANALYSER, MODEL 110WPMarch 4, 1986
K854546MICROSAMPLE COAGULATION ANALYSER MODEL 110PJanuary 7, 1986
K853897CITREX HOctober 10, 1985
K853246CALCIUM CHLORIDEAugust 13, 1985
K853077CITREX IIAugust 12, 1985
K852484PLASTINEXAugust 12, 1985
K852195CEPHALINEX ACTIVATED PTT REAGENTAugust 12, 1985
K853076CITREX IAugust 12, 1985
K853078CITREX IIIAugust 12, 1985
K845000THROMBINEX BOVINE THROMBINMarch 26, 1985
K843207REPTILASE -PCOctober 23, 1984
K834301THROMBOLYTIC ACTIVITY TESTFebruary 4, 1984
K821005PLATELET AGGREGATION PROFILER #PAP-4June 1, 1982
K812108LOW FIBRINOGEN CONTROLSeptember 24, 1981