Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
321 devices
Cleared
Sep 17, 2007
HEMOSIL D-DIMER HS
Hematology
167d
Cleared
Aug 15, 2007
HEMOSIL RECOMBIPLASTIN 2G
Hematology
224d
Cleared
Mar 29, 2007
HEMOSIL PROCLOT
Hematology
22d
Cleared
Feb 23, 2007
HEMOSIL ANTITHROMBIN
Hematology
23d
Cleared
Jan 12, 2007
ACL TOP
Hematology
32d
Cleared
Sep 22, 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
Chemistry
106d
Cleared
Sep 15, 2006
GEM PREMIER 4000 WITH IQM, MODEL 4000
Chemistry
65d
Cleared
Sep 01, 2006
HEMOSIL PROTEIN C
Hematology
11d
Cleared
Sep 01, 2006
HEMOSIL LIQUID ANTITHROMBIN
Hematology
11d
Cleared
May 02, 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
Hematology
27d
Cleared
Apr 13, 2006
HEMOSIL SYNTHASIL
Hematology
29d
Cleared
Feb 21, 2006
ACL ELITE
Hematology
29d
Cleared
Jan 13, 2006
HEMOSIL PROS
Hematology
28d
Cleared
Oct 21, 2005
GEM PREMIER 3000
Chemistry
77d
Cleared
May 02, 2005
HEMOSIL FACTOR II DEFICIENT PLASMA
Hematology
48d
Cleared
Apr 26, 2005
HEMOSIL D-DIMER HS
Hematology
55d
Cleared
Mar 30, 2005
HEMOSIL SILICA CLOTTING TIME
Hematology
58d
Cleared
Mar 10, 2005
HEMOSIL D-DIMER
Hematology
31d
Cleared
Feb 09, 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
Hematology
56d
Cleared
Dec 22, 2004
QUANTEX MYOGLOBIN
Chemistry
54d
Cleared
Dec 22, 2004
HEMOSIL RECOMBIPLASTIN
Hematology
35d
Cleared
Dec 02, 2004
COATEST SP FVIII
Hematology
71d
Cleared
Sep 28, 2004
HEMOSIL CALIBRATION PLASMA
Hematology
75d
Cleared
May 10, 2004
QUANTEX FERRITIN
Immunology
35d
Cleared
Apr 30, 2004
HEMOSIL VON WILLEBRAND ACTIVITY
Hematology
29d
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