Medical Device Manufacturer · US , Walker , MI

International Technidyne Corp. - FDA 510(k) Cleared Devices

47 submissions · 47 cleared · Since 1983
47
Total
47
Cleared
0
Denied
42 devices
26-42 of 42
Cleared Feb 11, 1992
HEMOCHRON ONESTEP APTT TEST
K915344 · GFO
Hematology · 77d
Cleared Oct 18, 1991
HEMOCHRON(R) KACT
K913861 · JBP
Hematology · 52d
Cleared Jul 17, 1991
HEMOCHRON(R) APTT, MODIFICATION
K911994 · GFO
Hematology · 86d
Cleared Jul 17, 1991
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
K911995 · GJS
Hematology · 86d
Cleared Jul 17, 1991
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
K911996 · JCA
Hematology · 86d
Cleared Jul 17, 1991
TENDERFOOT(R), MODIFICATION
K911997 · FMK
Hematology · 86d
Cleared May 10, 1991
HITT BY HEMOCHRON(R)
K910181 · KFF
Hematology · 114d
Cleared Feb 26, 1991
PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
K910105 · GFT
Hematology · 54d
Cleared Dec 17, 1990
HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION
K904454 · GJS
Hematology · 91d
Cleared Feb 05, 1990
TT AND HNTT BY HEMOCHRON
K900126 · GJA
Hematology · 27d
Cleared Jun 22, 1989
PROTHROMBIN TIME (PT) BY HEMOCHRON
K893378 · GJS
Hematology · 52d
Cleared Dec 01, 1988
TENDERFOOT
K883968 · FMK
Hematology · 72d
Cleared Aug 30, 1988
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
K882480 · GGN
Hematology · 75d
Cleared Aug 30, 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
K882481 · GGN
Hematology · 75d
Cleared Jun 01, 1987
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
K870831 · JPA
Hematology · 90d
Cleared Mar 01, 1985
SURGICUTT - BLEEDING TIME DEVICE
K850542 · JCA
Hematology · 18d
Cleared Oct 14, 1983
HEMOCHRON THROMBOCHRONOMETER
K832189 · JBP
Hematology · 98d
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