Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
321 devices
Cleared
Jan 25, 1995
IL TEST CARBAMAZEPINE, PN 181754-00
Toxicology
232d
Cleared
Jan 25, 1995
IL TEST GENTAMICIN CALIBRATORS
Toxicology
232d
Cleared
Jan 18, 1995
IL TEST THEOPHYLLINE
Toxicology
225d
Cleared
Jan 18, 1995
IL TEST PHENOBARBITAL CALIBRATORS
Toxicology
225d
Cleared
Nov 28, 1994
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
Chemistry
126d
Cleared
Mar 30, 1994
ASSESS(TM) LOW ABNORMAL CONTROL
Hematology
391d
Cleared
Mar 30, 1994
ASSESS(TM) HIGH ABNORMAL CONTROL
Hematology
391d
Cleared
Mar 28, 1994
IL TEST(TM) TRIGLYCERIDE
Toxicology
389d
Cleared
Mar 28, 1994
IL1430 BGELECTROLYTE ANALYZER
Chemistry
154d
Cleared
Feb 07, 1994
IL TEST HEPARIN (XA), PN 84699-15
Hematology
101d
Cleared
Feb 01, 1994
IL TEST CALCIUM
Chemistry
321d
Cleared
Nov 05, 1993
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM
Chemistry
165d
Cleared
Oct 12, 1993
IL TEST GLUCOSE
Chemistry
207d
Cleared
Oct 04, 1993
IL TEST (TM) PT-FIBRINOGEN HS PLUS
Hematology
94d
Cleared
Oct 01, 1993
IL TEST URIC ACID
Chemistry
198d
Cleared
Oct 01, 1993
IL TEST CARBAMAZEPHINE
Toxicology
64d
Cleared
Aug 13, 1993
IL TEST FIBRINOGEN-C
Hematology
128d
Cleared
Jun 18, 1993
IL MCL-2 COAGULATION ANALYZER
Hematology
309d
Cleared
May 11, 1993
IL TEST PHOSPHORUS
Chemistry
55d
Cleared
Apr 12, 1993
IL TEST(TM) PROTEIN S
Hematology
80d
Cleared
Feb 05, 1993
IL TEST CALIBRATION SET APO A1B
Immunology
225d
Cleared
Jan 14, 1993
IL TEST(TM) PRO-CHROM
Hematology
108d
Cleared
Oct 26, 1992
IL TEST APOLIPOROTEIN B (APO B)
Immunology
123d
Cleared
Oct 26, 1992
IL TEST APOLIPOPROTEIN A1
Immunology
123d
Cleared
Oct 26, 1992
IL TEST AST, PN 35312
Chemistry
97d
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