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
149 devices
126-149 of 149
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 Nov 02, 1981
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
K812556 · JJY
Immunology · 55d
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 24, 1981
BOVINE CHEMISTRY CONTROL I.X. & II.X.
K812583 · JJY
Chemistry · 14d
Cleared Sep 23, 1981
PROTEIN-BASED BLOOD GAS CONTROL
K812541 · JJS
Chemistry · 19d
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 May 15, 1981
DADE RPR CARD TEST
K811152 · GMQ
Microbiology · 18d
Cleared Mar 31, 1981
DADE RH CONTROL REAGENT
K810599 · KSF
Hematology · 25d
Cleared Feb 19, 1981
ARTERIAL MICROCOLLECTION SET
K810308 · CHL
Hematology · 14d
Cleared Feb 17, 1981
ALPHA-ANTIPLASM ASSAY
K802840 · LGP
Chemistry · 97d
Cleared Feb 17, 1981
PROTEOLYTIC ENZYME CONTROL
K803110 · LGP
Chemistry · 69d
Cleared Jan 02, 1981
IMMU-TRACE T3 UPTAKE (T3U) REAGENTS
K803044 · KHQ
Chemistry · 32d
Cleared Jan 02, 1981
IMMU-TRACE T4 RIA PROCEDURE
K803046 · CDX
Chemistry · 32d
Cleared Dec 22, 1980
IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.
K803045 · DOG
Toxicology · 21d
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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