American Dade - FDA 510(k) Cleared Devices
149
Total
149
Cleared
0
Denied
149 devices
Cleared
Apr 04, 1984
CREATINE KINASE MB REAGENT
Chemistry
49d
Cleared
Mar 09, 1984
STRATUS THYROID UPTAKE FLUOROMETRIC
Chemistry
95d
Cleared
Mar 09, 1984
PARAMAX ALANINE AMINOTRANSFERASE
Hematology
21d
Cleared
Mar 05, 1984
STRATUS TOTAL THYROXINE FLUOROMETRIC
Chemistry
91d
Cleared
Feb 04, 1984
PROTOPATH FACTOR IX ASSAY
Hematology
73d
Cleared
Feb 04, 1984
PROTOPATH FACTOR VIII ASSAY
Hematology
73d
Cleared
Dec 30, 1983
STRATUS THEOPHYLLINE ASSAY
Chemistry
120d
Cleared
Dec 22, 1983
ACLAIM-QAP IBM PERSONAL COMPUTER EDT
Chemistry
85d
Cleared
Nov 14, 1983
PARAMAX BILIRUBIN CALIBRATORS
Chemistry
94d
Cleared
Nov 03, 1983
THROMBOPLASTIN - FS
Hematology
43d
Cleared
Oct 28, 1983
PARAMAX SALICYLATE REAGENT
Chemistry
77d
Cleared
Oct 14, 1983
PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS
Chemistry
63d
Cleared
Oct 14, 1983
PARAMAX & GLUTAMYTRANSFERASE REAGENT
Chemistry
63d
Cleared
Oct 14, 1983
PARAMAX PHOSPHORUS REAGENT
Chemistry
63d
Cleared
Oct 14, 1983
PARAMAX TOTAL BILIRUBIN REAGENT
Chemistry
63d
Cleared
Sep 12, 1983
STRATUS CARBAMAZEPINE FLUROMETRIC
Chemistry
49d
Cleared
Aug 31, 1983
STRATUS AMIKACIN FLUOROMETRIC
Chemistry
44d
Cleared
Aug 31, 1983
STRATUS GENTAMICIN FLUOROMETRIC ENZYM
Chemistry
37d
Cleared
Aug 26, 1983
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
Chemistry
36d
Cleared
Aug 10, 1983
AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
Chemistry
49d
Cleared
Jun 22, 1983
PARAMAX ALKALINE PHOSPHATASE REAGENT-
Chemistry
44d
Cleared
Jun 22, 1983
PARAMAX CREATINE KINASE REAGENT
Chemistry
44d
Cleared
Jun 17, 1983
PARAMAX AMALINE REAGENT
Chemistry
39d
Cleared
Jun 08, 1983
DADE HEMATOLOGY CALIBRATOR
Hematology
62d
Cleared
Jun 08, 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
Chemistry
48d
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