Hemotec, Inc. - FDA 510(k) Cleared Devices
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hemotec, Inc. Hematology ✕
15 devices
Cleared
Jul 03, 1990
CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
Hematology
56d
Cleared
Sep 05, 1989
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
Hematology
53d
Cleared
Sep 05, 1989
CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS
Hematology
53d
Cleared
Sep 05, 1989
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
Hematology
49d
Cleared
Jan 10, 1989
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
Hematology
68d
Cleared
Mar 09, 1988
HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
Hematology
91d
Cleared
Feb 19, 1988
CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER
Hematology
25d
Cleared
Dec 04, 1985
HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS
Hematology
35d
Cleared
Dec 04, 1985
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
Hematology
35d
Cleared
Oct 04, 1985
ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR
Hematology
24d
Cleared
Dec 12, 1984
HEMOTEC ACT I SYSTEM
Hematology
98d
Cleared
May 25, 1984
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
Hematology
74d
Cleared
Jun 08, 1983
HEPCOL SYSTEM B-10 & B-10-P
Hematology
97d
Cleared
Apr 09, 1982
HEMOTEC HEPCON/SYSTEM FOUR & FOUR P
Hematology
56d
Cleared
Mar 19, 1980
HEPCON/SYSTEM RC-10
Hematology
55d