Fujirebio Diagnostics,Inc. - FDA 510(k) Cleared Devices
45
Total
43
Cleared
1
Denied
45 devices
Cleared
May 27, 2011
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
Chemistry
84d
Cleared
May 26, 2011
CYFRA 21-1 EIA MODEL 211-10
Immunology
428d
Cleared
Apr 20, 2011
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
Chemistry
64d
Cleared
Jan 25, 2011
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
Chemistry
62d
Cleared
Oct 05, 2010
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
Immunology
98d
Cleared
Sep 24, 2010
FDI GLUCOSE CONTROL SOLUTIONS
Chemistry
45d
Cleared
Mar 18, 2010
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS...
Immunology
85d
Cleared
Sep 05, 2009
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
Chemistry
9d
Cleared
Sep 11, 2008
ARCHITECT CYCLOSPORINE
Toxicology
177d
Cleared
Jun 09, 2008
HE4 EIA, MODEL: 404-10 US
Immunology
236d
Cleared
Sep 28, 2007
ARCHITECT SIROLIMUS ASSAY
Toxicology
186d
Cleared
Aug 01, 2007
ARCHITECT TACROLIMUS: MODEL 1L77
Toxicology
128d
Cleared
May 25, 2006
ARCHITECT BNP ASSAY, MODEL 8K28
Chemistry
48d
Cleared
Dec 20, 2005
VITROS CA 19-9
Immunology
68d
Cleared
Oct 25, 2005
ARCHITECT CA 19-9XR ASSAY
Immunology
92d
Cleared
Dec 22, 2004
ARCHITECT CA 15-3 ASSAY
Immunology
82d
Cleared
Nov 19, 2004
ARCHITECT CA 125 II ASSAY
Immunology
49d
Cleared
Feb 20, 2004
AXSYM CORTISOL ASSAY
Chemistry
84d
Cleared
May 09, 2002
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
Immunology
78d
Cleared
Nov 17, 1989
OLYMPUS PK(TM) TP
Microbiology
206d