Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
126 devices
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 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
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
Jul 07, 1998
IL TEST PT-FIBRINOGEN RECOMBINANT
Hematology
74d
Cleared
May 26, 1998
IL TEST PLASMINOGEN
Hematology
54d
Cleared
May 01, 1998
COAMATIC PLASMINOGEN
Hematology
135d
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
Nov 04, 1997
IL TEST D-DIMER
Hematology
109d
Cleared
Nov 04, 1997
IL TEST APTT-SP
Hematology
62d
Cleared
Sep 04, 1996
ACL 6000 SYSTEM (ACL 6000)
Hematology
106d
Cleared
Nov 03, 1995
ACL FUTURA COAGULATION SYSTEM
Hematology
193d
Cleared
Oct 20, 1995
IL682, CO-OXIMETER
Hematology
336d
Cleared
Mar 30, 1994
ASSESS(TM) LOW ABNORMAL CONTROL
Hematology
391d
Cleared
Mar 30, 1994
ASSESS(TM) HIGH ABNORMAL CONTROL
Hematology
391d
Cleared
Feb 07, 1994
IL TEST HEPARIN (XA), PN 84699-15
Hematology
101d
Cleared
Oct 04, 1993
IL TEST (TM) PT-FIBRINOGEN HS PLUS
Hematology
94d
Cleared
Aug 13, 1993
IL TEST FIBRINOGEN-C
Hematology
128d
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