Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
126 devices
Cleared
Feb 05, 2010
HEMOSIL D-DIMER HS 500, CONTROLS
Hematology
367d
Cleared
Oct 09, 2009
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
Hematology
221d
Cleared
Sep 22, 2009
ACL TOP 700 LAS
Hematology
83d
Cleared
Jun 02, 2009
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
Hematology
125d
Cleared
Mar 13, 2009
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
Hematology
107d
Cleared
Dec 19, 2008
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
Hematology
81d
Cleared
May 04, 2008
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
Hematology
153d
Cleared
Dec 27, 2007
HEMOSIL FIBRINOGEN-C
Hematology
27d
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 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
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
HEMOSIL RECOMBIPLASTIN
Hematology
35d
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