American Dade - FDA 510(k) Cleared Devices
149
Total
149
Cleared
0
Denied
149 devices
Cleared
May 17, 1983
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
Immunology
36d
Cleared
May 16, 1983
STRATUS PHENYTOIN FLUOROMETRIC ENZYME
Immunology
38d
Cleared
May 16, 1983
LITHIUM HEPARINIZED BLOOD COLLECT-TUBE
Hematology
31d
Cleared
May 13, 1983
STRATUS PHENOBARBITAL FLUOROMETRIC ENZ
Toxicology
67d
Cleared
Mar 17, 1983
BLEEDING TIME DEVICE DISPOSABLE
Hematology
16d
Cleared
Mar 07, 1983
PARAMAX ANALYTICAL SYS
Chemistry
35d
Cleared
Feb 07, 1983
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
Chemistry
90d
Cleared
Dec 28, 1982
DADE ESR KIT
Hematology
48d
Cleared
Nov 16, 1982
QAP MICROCOMPUTER SYSTEM
Chemistry
26d
Cleared
Oct 27, 1982
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
Chemistry
34d
Cleared
Sep 14, 1982
THROMBIN TIME TEST
Hematology
29d
Cleared
Aug 25, 1982
DISPOSABLE DISPENSING-SPREAD PIPETS
Chemistry
23d
Cleared
Aug 05, 1982
DADE CHILL TRAY
Chemistry
16d
Cleared
Jul 27, 1982
DADE DISP. DISPENSING-SPREADING PIPETS
Chemistry
12d
Cleared
May 14, 1982
STRATUS TDM CONTROL, LEVELS I,II,III
Chemistry
99d
Cleared
Apr 14, 1982
LECTIN-A
Hematology
64d
Cleared
Mar 04, 1982
LECTIN H
Pathology
87d
Cleared
Feb 23, 1982
DADE FACTOR ASSAY REFERENCE PLASMA
Hematology
42d
Cleared
Feb 22, 1982
HEMOTOLOGY CALIBRATOR
Hematology
67d
Cleared
Feb 22, 1982
CLOTTING TIME REAGENT
Hematology
41d
Cleared
Jan 28, 1982
TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY
Chemistry
21d
Cleared
Dec 31, 1981
DADE COLORIMETRIC AMYLASE
Chemistry
14d
Cleared
Nov 24, 1981
S/P VORTEX MIXER
Chemistry
18d
Cleared
Nov 24, 1981
S/P VORTEX MIXER JR.
Chemistry
18d
Cleared
Nov 06, 1981
S/P SURE-CAP
Hematology
18d
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