Instrumentation Laboratory CO - FDA 510(k) Cleared Devices
321
Total
320
Cleared
1
Denied
321 devices
Cleared
Mar 03, 2016
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL...
Hematology
30d
Cleared
Dec 13, 2015
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
Hematology
256d
Cleared
Jul 06, 2015
HemosIL D-Dimer HS
Hematology
28d
Cleared
Mar 13, 2014
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY
Hematology
169d
Cleared
Jan 22, 2014
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
Hematology
145d
Cleared
Jan 13, 2014
GEM PREMIER 4000
Chemistry
68d
Cleared
Mar 24, 2013
HEMOSIL READIPLAS TIN
Hematology
212d
Cleared
May 03, 2012
GEM PREMIER 4000
Chemistry
209d
Cleared
Jan 04, 2012
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
Hematology
65d
Cleared
Aug 24, 2011
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
Hematology
231d
Cleared
Jul 08, 2011
HEMOSIL FACTOR VIII DEFICIENT PLASMA
Hematology
163d
Cleared
Apr 05, 2011
HEMOSIL LA POSITIVE CONTROL
Hematology
210d
Cleared
Mar 17, 2011
HEMOSIL PROTEIN S ACTIVITY ASSAY
Hematology
227d
Cleared
Jun 18, 2010
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2...
Chemistry
207d
Cleared
May 21, 2010
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
Immunology
359d
Cleared
May 04, 2010
HEMOSIL F11 & FV DNA CONTROL
Pathology
151d
Cleared
Mar 11, 2010
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
Immunology
233d
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
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