Hemotec, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K902081CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROLJuly 3, 1990
K894317HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.September 5, 1989
K894466HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLSSeptember 5, 1989
K894359CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLSSeptember 5, 1989
K884590HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGESJanuary 10, 1989
K875089HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARINMarch 9, 1988
K880302CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFERFebruary 19, 1988
K854376HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLSDecember 4, 1985
K854377HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLSDecember 4, 1985
K853789ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAROctober 4, 1985
K843459HEMOTEC ACT I SYSTEMDecember 12, 1984
K841021HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAMMay 25, 1984
K830665HEPCOL SYSTEM B-10 & B-10-PJune 8, 1983
K820410HEMOTEC HEPCON/SYSTEM FOUR & FOUR PApril 9, 1982
K800161HEPCON/SYSTEM RC-10March 19, 1980