Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
321 devices
Cleared
Mar 19, 2004
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
Hematology
35d
Cleared
Feb 13, 2004
HEMOSIL FACTOR VIII DEFICIENT PLASMA
Hematology
51d
Cleared
Jan 12, 2004
ACL TOP MODEL, TOP
Hematology
77d
Cleared
Jan 02, 2004
HEMOSIL LIQUID ANTITHROMBIN XL
Hematology
30d
Cleared
Dec 19, 2003
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH...
Chemistry
113d
Cleared
Dec 15, 2003
MODIFICATION TO COATEST FACTOR VIII
Hematology
26d
Cleared
Oct 24, 2003
QUANTEX D-DIMER
Hematology
80d
Cleared
Jul 31, 2003
HEMOSIL FACTOR IX DEFICIENT PLASMA
Hematology
48d
Cleared
Jun 06, 2003
CALIBRATION PLASMA LMW HEPARIN
Hematology
71d
Cleared
Jun 06, 2003
CONTROL PLASMA LMW HEPARIN
Hematology
71d
Cleared
May 19, 2003
HEMOSIL FACTOR X DEFICIENT PLASMA
Hematology
41d
Cleared
Mar 19, 2003
HEMOSIL FACTOR XI DEFICIENT PLASMA
Hematology
50d
Cleared
Feb 24, 2003
BIORAPID MONONUCLEOSIS
Immunology
34d
Cleared
Feb 12, 2003
HEMOSIL FACTOR VII DEFICIENT PLASMA
Hematology
63d
Cleared
Jan 14, 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
Hematology
57d
Cleared
Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
Chemistry
83d
Cleared
Sep 10, 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP...
Chemistry
70d
Cleared
Aug 27, 2002
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
Hematology
25d
Cleared
Aug 07, 2002
COAMATIC AT-400
Hematology
33d
Cleared
May 16, 2002
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
Hematology
48d
Cleared
May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
Hematology
46d
Cleared
May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
Hematology
46d
Cleared
Sep 27, 2001
COLOR-MONOGEN
Immunology
29d
Cleared
Sep 18, 2001
HEMOSIL RECOMBI PLASTIN
Hematology
32d
Cleared
Jun 25, 2001
IL TEST PROS
Hematology
47d
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