Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
119 devices
Cleared
Jan 27, 1992
IL TEST(TM) BENZODIAZEPINE
Chemistry
94d
Cleared
Jan 22, 1992
IL TEST(TM) CALIBRATION SET SP
Chemistry
82d
Cleared
Jan 09, 1992
IL TEST(TM) HDL CHOLESTEROL
Chemistry
76d
Cleared
Oct 11, 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
Chemistry
38d
Cleared
Jun 10, 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
Chemistry
38d
Cleared
Apr 03, 1991
IL THEOPHYLLINE ASSAY SYSTEM
Chemistry
43d
Cleared
Nov 20, 1990
P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
Chemistry
32d
Cleared
Oct 12, 1990
IL T UPTAKE ASSAY SYSTEM
Chemistry
77d
Cleared
Aug 23, 1990
IL THYROXINE (T4) ASSAY SYSTEM
Chemistry
41d
Cleared
Aug 22, 1990
IL TOBRAMYCIN ASSAY
Chemistry
34d
Cleared
Sep 28, 1989
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
Chemistry
59d
Cleared
Jun 20, 1989
IL1400, BGELECTROLYTE ANALYZER
Chemistry
119d
Cleared
Feb 10, 1989
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
Chemistry
88d
Cleared
Oct 20, 1987
IL 35260, IL TEST AMYLASE REAGENT
Chemistry
48d
Cleared
Jun 11, 1987
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.
Chemistry
20d
Cleared
May 08, 1987
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR
Chemistry
10d
Cleared
Jul 29, 1986
IL 482 CO-OXIMETER
Chemistry
46d
Cleared
Dec 11, 1984
REFERRIL CALIBRATORS
Chemistry
18d
Cleared
Dec 11, 1984
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS
Chemistry
18d
Cleared
Jul 11, 1984
IL 1312, PH BLOOD GAS MANAGER
Chemistry
51d
Cleared
Jan 11, 1984
IL MODEL 840 MICROPROCESSOR LOADER
Chemistry
92d
Cleared
Jan 04, 1984
IL TEST IGG IGA & IGM KITS
Chemistry
58d
Cleared
Feb 28, 1983
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
Chemistry
42d
Cleared
Jan 09, 1983
IL 943 FLAME PHOTOMETER
Chemistry
47d
Cleared
Jun 10, 1982
IL 1302 PH BLOOD GAS ANALYZER
Chemistry
23d
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