Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
321 devices
Cleared
Dec 17, 1997
IL TEST UREA NITROGEN
Chemistry
29d
Cleared
Nov 04, 1997
IL TEST D-DIMER
Hematology
109d
Cleared
Nov 04, 1997
IL TEST APTT-SP
Hematology
62d
Cleared
Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
Immunology
40d
Cleared
Aug 19, 1997
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
Chemistry
15d
Cleared
Aug 15, 1997
IL TEST IRON
Chemistry
51d
Cleared
May 27, 1997
QUANTEX ASO-CRP-RF CONTROL
Chemistry
13d
Cleared
Nov 13, 1996
IL SYNTHESIS
Chemistry
51d
Cleared
Sep 26, 1996
QUANTEX C4
Immunology
111d
Cleared
Sep 26, 1996
QUANTEX IGG
Immunology
111d
Cleared
Sep 25, 1996
QUANTEX C3
Immunology
110d
Cleared
Sep 25, 1996
QUANTEX IGA
Immunology
110d
Cleared
Sep 25, 1996
QUANTEX IGM
Immunology
110d
Cleared
Sep 04, 1996
ACL 6000 SYSTEM (ACL 6000)
Hematology
106d
Cleared
Feb 14, 1996
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
Chemistry
54d
Cleared
Feb 05, 1996
IL TEST CHOLINESTERASE
Chemistry
572d
Cleared
Jan 29, 1996
IL TEST ACID PHOSPHATASE
Chemistry
565d
Cleared
Nov 03, 1995
ACL FUTURA COAGULATION SYSTEM
Hematology
193d
Cleared
Oct 20, 1995
IL682, CO-OXIMETER
Hematology
336d
Cleared
Aug 04, 1995
IL TEST CK-MB
Chemistry
56d
Cleared
Jul 20, 1995
IL TEST LIPASE
Chemistry
41d
Cleared
Jun 09, 1995
IL TEST DIGOXIN, PN 181761-00
Toxicology
74d
Cleared
May 15, 1995
IL TEST BETA-2MICROGLOBULIN
Immunology
290d
Cleared
May 01, 1995
IL TEST PHENYTION CALIBRATORS
Toxicology
328d
Cleared
Apr 10, 1995
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
Toxicology
307d
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