Medical Device Manufacturer · US , Mchenry , IL

American Dade - FDA 510(k) Cleared Devices

149 submissions · 149 cleared · Since 1980
149
Total
149
Cleared
0
Denied
46 devices
26-46 of 46
Cleared Sep 14, 1982
THROMBIN TIME TEST
K822466 · GJA
Hematology · 29d
Cleared Apr 14, 1982
LECTIN-A
K820368 · KSI
Hematology · 64d
Cleared Feb 23, 1982
DADE FACTOR ASSAY REFERENCE PLASMA
K820085 · GGP
Hematology · 42d
Cleared Feb 22, 1982
HEMOTOLOGY CALIBRATOR
K813530 · KSA
Hematology · 67d
Cleared Feb 22, 1982
CLOTTING TIME REAGENT
K820084 · GJB
Hematology · 41d
Cleared Nov 06, 1981
S/P SURE-CAP
K812921 · GIO
Hematology · 18d
Cleared Nov 06, 1981
S/P SURE-CAP C
K812922 · GIO
Hematology · 18d
Cleared Nov 06, 1981
S/P SURE-CAP N
K812923 · GIO
Hematology · 18d
Cleared Nov 06, 1981
S/P CAPILLARY TUBES, HEPARINIZED (2A)
K812969 · GIO
Hematology · 15d
Cleared Nov 06, 1981
S/P CAPILLARY TUBES, HEPARINIZED (3A)
K812970 · GIO
Hematology · 15d
Cleared Oct 27, 1981
S/P SERUM DROPPER PIPETS
K812892 · KSS
Hematology · 12d
Cleared Oct 02, 1981
CI-TROL HEPARIN CONTROLS, LOW/HIGH
K812424 · KFF
Hematology · 39d
Cleared Sep 09, 1981
HEMOTOLOGY QUALITY CONTROL MIXTURE
K812237 · JPK
Hematology · 29d
Cleared Sep 09, 1981
HEMATOLOGY CONTROL
K812280 · JPK
Hematology · 27d
Cleared Jul 16, 1981
ACTIN FS ACTIVATED PTT REAGENT
K811589 · GGW
Hematology · 38d
Cleared Jul 10, 1981
FIBRINOGEN CONTROL PLASMA
K811069 · KQJ
Hematology · 81d
Cleared Mar 31, 1981
DADE RH CONTROL REAGENT
K810599 · KSF
Hematology · 25d
Cleared Feb 19, 1981
ARTERIAL MICROCOLLECTION SET
K810308 · CHL
Hematology · 14d
Cleared Oct 10, 1980
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL
K802141 · JPK
Hematology · 35d
Cleared Oct 10, 1980
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL
K802142 · JPK
Hematology · 35d
Cleared Oct 10, 1980
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET
K802143 · JPK
Hematology · 35d
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