General Diagnostics - FDA 510(k) Cleared Devices
39
Total
39
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Diagnostics Hematology ✕
11 devices
Cleared
Jan 21, 1983
VON WILLEBRAND FACTOR ASSAY
Hematology
65d
Cleared
Jan 14, 1983
CONTROL TM 8
Hematology
29d
Cleared
Jan 28, 1982
COAG-A-MATE X2
Hematology
37d
Cleared
Sep 26, 1980
FIBRI QUIK
Hematology
22d
Cleared
Jul 21, 1980
VERIFY S PROD. #34141
Hematology
91d
Cleared
May 08, 1980
THROMBOQUIK THROMBIN REAGENT PROD. #3551
Hematology
17d
Cleared
Mar 21, 1979
COAG-A-MATE 2001
Hematology
34d
Cleared
Jan 10, 1979
HEPARSORB
Hematology
83d
Cleared
Nov 08, 1978
SULFATE, FIBRIQUIK PROTAMINE
Hematology
13d
Cleared
Mar 30, 1978
SOLUBLE COLLAGEN
Hematology
37d
Cleared
Mar 01, 1977
SIMPLATE
Hematology
78d