American Dade - FDA 510(k) Cleared Devices
149
Total
149
Cleared
0
Denied
46 devices
Cleared
Sep 14, 1982
THROMBIN TIME TEST
Hematology
29d
Cleared
Apr 14, 1982
LECTIN-A
Hematology
64d
Cleared
Feb 23, 1982
DADE FACTOR ASSAY REFERENCE PLASMA
Hematology
42d
Cleared
Feb 22, 1982
HEMOTOLOGY CALIBRATOR
Hematology
67d
Cleared
Feb 22, 1982
CLOTTING TIME REAGENT
Hematology
41d
Cleared
Nov 06, 1981
S/P SURE-CAP
Hematology
18d
Cleared
Nov 06, 1981
S/P SURE-CAP C
Hematology
18d
Cleared
Nov 06, 1981
S/P SURE-CAP N
Hematology
18d
Cleared
Nov 06, 1981
S/P CAPILLARY TUBES, HEPARINIZED (2A)
Hematology
15d
Cleared
Nov 06, 1981
S/P CAPILLARY TUBES, HEPARINIZED (3A)
Hematology
15d
Cleared
Oct 27, 1981
S/P SERUM DROPPER PIPETS
Hematology
12d
Cleared
Oct 02, 1981
CI-TROL HEPARIN CONTROLS, LOW/HIGH
Hematology
39d
Cleared
Sep 09, 1981
HEMOTOLOGY QUALITY CONTROL MIXTURE
Hematology
29d
Cleared
Sep 09, 1981
HEMATOLOGY CONTROL
Hematology
27d
Cleared
Jul 16, 1981
ACTIN FS ACTIVATED PTT REAGENT
Hematology
38d
Cleared
Jul 10, 1981
FIBRINOGEN CONTROL PLASMA
Hematology
81d
Cleared
Mar 31, 1981
DADE RH CONTROL REAGENT
Hematology
25d
Cleared
Feb 19, 1981
ARTERIAL MICROCOLLECTION SET
Hematology
14d
Cleared
Oct 10, 1980
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
Hematology
35d
Cleared
Oct 10, 1980
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
Hematology
35d
Cleared
Oct 10, 1980
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
Hematology
35d