American Dade - FDA 510(k) Cleared Devices
149
Total
149
Cleared
0
Denied
149 devices
Cleared
Apr 11, 1986
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
Chemistry
66d
Cleared
Mar 17, 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
Chemistry
46d
Cleared
Feb 19, 1986
PARAMAX COMPREHENSIVE CALIBRATOR
Chemistry
54d
Cleared
Feb 11, 1986
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
Toxicology
28d
Cleared
Feb 11, 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
Chemistry
7d
Cleared
Feb 06, 1986
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
Toxicology
23d
Cleared
Dec 13, 1985
PARAAMAX CHLORIDE DETERMINATION BY ISE
Chemistry
24d
Cleared
Nov 12, 1985
THROMBOPLASTIN-R REAGENT
Hematology
46d
Cleared
Sep 18, 1985
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
Chemistry
23d
Cleared
Sep 16, 1985
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
Chemistry
21d
Cleared
Sep 04, 1985
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
Chemistry
12d
Cleared
Aug 29, 1985
COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
Hematology
10d
Cleared
Aug 29, 1985
COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA
Hematology
10d
Cleared
Jul 09, 1985
DADE BLOOD GAS AMPUL INJECTOR
Chemistry
41d
Cleared
Apr 12, 1985
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
Immunology
58d
Cleared
Apr 10, 1985
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H
Chemistry
56d
Cleared
Apr 02, 1985
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
Chemistry
48d
Cleared
Nov 19, 1984
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
Immunology
26d
Cleared
Nov 19, 1984
SERIES I/S INFECTIONS
Immunology
14d
Cleared
Oct 01, 1984
VON WILLEBRAND FACTOR ANTIGEN SCREEN
Hematology
95d
Cleared
Oct 01, 1984
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT
Hematology
88d
Cleared
Sep 26, 1984
STRATUS LIDOCAINE FLUOROMETRIC ENZYME
Immunology
44d
Cleared
Sep 17, 1984
STRATUS CORTISOL FLUOROMETRIC ENZYME
Chemistry
35d
Cleared
Sep 12, 1984
STRATUS QUINIDINE FLUOROMETRIC ENZYME
Toxicology
21d
Cleared
Jul 11, 1984
STRATUS PRIMIDONE FLOROMETRIC ENZY
Toxicology
37d
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