Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
321 devices
Cleared
May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
Chemistry
74d
Cleared
Apr 13, 2001
IL TEST FREE PROTEIN S
Hematology
64d
Cleared
Oct 13, 2000
COALIZA PROTEIN S-FREE
Hematology
63d
Cleared
Aug 30, 2000
MODIFICATION OF ACL ADVANCE
Hematology
26d
Cleared
Jun 23, 2000
IL TEST LIQUID ANTITHROMBIN
Hematology
190d
Cleared
Mar 15, 2000
ACL 9000 SYSTEM
Hematology
68d
Cleared
Nov 24, 1999
GEM PREMIER 3000
Chemistry
93d
Cleared
Nov 01, 1999
IL TEST VON WILLEBRAND FACTOR
Hematology
81d
Cleared
Apr 08, 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS...
Hematology
66d
Cleared
Feb 02, 1999
QUANTEX ASO-CRP-RP CONTROL II
Chemistry
50d
Cleared
Nov 03, 1998
COAMATIC HEPARIN
Hematology
53d
Cleared
Sep 28, 1998
COAMATIC PLASMIN INHIBITOR
Hematology
129d
Cleared
Aug 27, 1998
IL TEST PLASMIN INHIBITOR
Hematology
105d
Cleared
Aug 06, 1998
TOXOGEN
Microbiology
121d
Cleared
Jul 07, 1998
IL TEST PT-FIBRINOGEN RECOMBINANT
Hematology
74d
Cleared
May 26, 1998
IL TEST PLASMINOGEN
Hematology
54d
Cleared
May 06, 1998
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE...
Chemistry
76d
Cleared
May 01, 1998
CMVGEN
Microbiology
157d
Cleared
May 01, 1998
COAMATIC PLASMINOGEN
Hematology
135d
Cleared
Apr 21, 1998
ILAB 600 CLINICAL CHEMISTRY SYSTEM
Chemistry
53d
Cleared
Apr 21, 1998
IL TEST PROTEIN C
Hematology
46d
Cleared
Apr 16, 1998
COAMATIC FACTOR VIII
Hematology
28d
Cleared
Apr 02, 1998
IL TEST ANTITHROMBIN
Hematology
52d
Cleared
Mar 19, 1998
IL TEST HEPARIN
Hematology
55d
Cleared
Dec 17, 1997
IL TEST AMYLASE
Chemistry
44d
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