Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
321 devices
Cleared
Nov 07, 1991
IL TEST(TM) OPIATE
Toxicology
79d
Cleared
Nov 07, 1991
IL TEST(TM) PHENCYCLIDINE
Toxicology
79d
Cleared
Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET B
Toxicology
62d
Cleared
Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET C
Toxicology
62d
Cleared
Oct 11, 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
Chemistry
38d
Cleared
Oct 09, 1991
IL TEST PROCLOT ASSAY STYSTEM
Hematology
112d
Cleared
Sep 19, 1991
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
Hematology
129d
Cleared
Sep 10, 1991
IL TEST(TM) DAT CALIBRATOR A( -)
Toxicology
21d
Cleared
Jun 10, 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
Chemistry
38d
Cleared
Apr 03, 1991
IL PHENOBARBITAL ASSAY SYSTEM
Toxicology
64d
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
Sep 17, 1990
IL GENTAMICIN ASSAY SYSTEM
Toxicology
32d
Cleared
Aug 23, 1990
IL THYROXINE (T4) ASSAY SYSTEM
Chemistry
41d
Cleared
Aug 22, 1990
IL PHENYTOIN ASSAY SYSTEM
Toxicology
48d
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
Jun 27, 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
Hematology
88d
Cleared
Feb 18, 1988
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
Hematology
91d
Cleared
Jan 27, 1988
CELLECT LABTRAK SOFTWARE
Hematology
98d
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
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