American Dade - FDA 510(k) Cleared Devices
149
Total
149
Cleared
0
Denied
83 devices
Cleared
Sep 17, 1984
STRATUS CORTISOL FLUOROMETRIC ENZYME
Chemistry
35d
Cleared
Jun 22, 1984
PARAMAX IRON REAGENT
Chemistry
46d
Cleared
Jun 22, 1984
PARAMAX IRON BLANK REAGENT
Chemistry
46d
Cleared
Apr 13, 1984
PARAMAX ALCOHOL REAGENT
Chemistry
65d
Cleared
Apr 13, 1984
ALCOHOL & AMMONIA CALIBRATOR I
Chemistry
65d
Cleared
Apr 13, 1984
ALCOHOL & AMMONIA CALIBRATOR II
Chemistry
65d
Cleared
Apr 13, 1984
LACTATE REAGENT
Chemistry
65d
Cleared
Apr 13, 1984
NEONATAL BILIRUBIN REAGENT
Chemistry
65d
Cleared
Apr 13, 1984
URIC ACID REAGENT
Chemistry
65d
Cleared
Apr 13, 1984
ALBUMIN REAGENT
Chemistry
58d
Cleared
Apr 13, 1984
PARAMAX MAGNESIUM REAGENT
Chemistry
58d
Cleared
Apr 13, 1984
PARAMAX TOTAL PROTEIN REAGENT TP
Chemistry
58d
Cleared
Apr 05, 1984
DIRECT BILIRUBIN REAGENT
Chemistry
57d
Cleared
Apr 05, 1984
TRIGLYCERIDES REAGENT
Chemistry
57d
Cleared
Apr 05, 1984
PARAMAX UREA NITROGEN REAGENT
Chemistry
50d
Cleared
Apr 04, 1984
PARAMAX AMMONIA REAGENTT
Chemistry
67d
Cleared
Apr 04, 1984
CARBON DIOXIDE REAGENT
Chemistry
56d
Cleared
Apr 04, 1984
CARBON DIOXIDE CALIBRATOR I
Chemistry
56d
Cleared
Apr 04, 1984
CARBON DIOXIDE CALIBRATOR II
Chemistry
56d
Cleared
Apr 04, 1984
PARAMAX CHOLESTEROL REAGENT
Chemistry
56d
Cleared
Apr 04, 1984
CREATINE KINASE MB REAGENT
Chemistry
49d
Cleared
Mar 09, 1984
STRATUS THYROID UPTAKE FLUOROMETRIC
Chemistry
95d
Cleared
Mar 05, 1984
STRATUS TOTAL THYROXINE FLUOROMETRIC
Chemistry
91d
Cleared
Dec 30, 1983
STRATUS THEOPHYLLINE ASSAY
Chemistry
120d
Cleared
Dec 22, 1983
ACLAIM-QAP IBM PERSONAL COMPUTER EDT
Chemistry
85d
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