International Technidyne Corp. - FDA 510(k) Cleared Devices
47
Total
47
Cleared
0
Denied
47 devices
Cleared
Jan 21, 1993
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM
Hematology
177d
Cleared
Jan 14, 1993
HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT
Hematology
135d
Cleared
Sep 22, 1992
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
Hematology
64d
Cleared
May 28, 1992
DIRECTDRAW SUPERSERUM
Chemistry
44d
Cleared
Feb 11, 1992
HEMOCHRON ONESTEP APTT TEST
Hematology
77d
Cleared
Oct 18, 1991
HEMOCHRON(R) KACT
Hematology
52d
Cleared
Jul 17, 1991
HEMOCHRON(R) APTT, MODIFICATION
Hematology
86d
Cleared
Jul 17, 1991
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
Hematology
86d
Cleared
Jul 17, 1991
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
Hematology
86d
Cleared
Jul 17, 1991
TENDERFOOT(R), MODIFICATION
Hematology
86d
Cleared
May 10, 1991
HITT BY HEMOCHRON(R)
Hematology
114d
Cleared
May 10, 1991
SUPERSERUM REAGENT (SSR)
Chemistry
86d
Cleared
Feb 26, 1991
PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
Hematology
54d
Cleared
Dec 17, 1990
HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION
Hematology
91d
Cleared
Feb 05, 1990
TT AND HNTT BY HEMOCHRON
Hematology
27d
Cleared
Jun 22, 1989
PROTHROMBIN TIME (PT) BY HEMOCHRON
Hematology
52d
Cleared
Dec 01, 1988
TENDERFOOT
Hematology
72d
Cleared
Aug 30, 1988
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
Hematology
75d
Cleared
Aug 30, 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
Hematology
75d
Cleared
Jun 01, 1987
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
Hematology
90d
Cleared
Mar 01, 1985
SURGICUTT - BLEEDING TIME DEVICE
Hematology
18d
Cleared
Oct 14, 1983
HEMOCHRON THROMBOCHRONOMETER
Hematology
98d