Fujirebio Diagnostics,Inc. - FDA 510(k) Cleared Devices
45
Total
43
Cleared
1
Denied
FDA 510(k) cleared devices by Fujirebio Diagnostics,Inc. Chemistry ✕
19 devices
Cleared
Aug 24, 2020
ST AIA-PACK BNP
Chemistry
360d
Cleared
Aug 30, 2019
Lumipulse G whole PTH
Chemistry
165d
Cleared
Jul 28, 2017
Lumipulse G TSH-III Immunoreaction Cartridges
Chemistry
106d
Cleared
Jan 13, 2017
Lumipulse G FSH-N Calibrators
Chemistry
28d
Cleared
Jan 13, 2017
Lumipulse G Progesterone-N Calibrators
Chemistry
28d
Cleared
Jan 12, 2017
Lumipulse G LH Calibrators
Chemistry
28d
Cleared
Jan 12, 2017
Lumipulse G Prolactin
Chemistry
27d
Cleared
Dec 01, 2016
Lumipulse G E2-III Calibrators
Chemistry
30d
Cleared
Apr 15, 2016
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
Chemistry
147d
Cleared
Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT...
Chemistry
305d
Cleared
Jan 17, 2014
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
Chemistry
92d
Cleared
Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
Chemistry
55d
Cleared
May 27, 2011
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
Chemistry
84d
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
Sep 24, 2010
FDI GLUCOSE CONTROL SOLUTIONS
Chemistry
45d
Cleared
Sep 05, 2009
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
Chemistry
9d
Cleared
May 25, 2006
ARCHITECT BNP ASSAY, MODEL 8K28
Chemistry
48d
Cleared
Feb 20, 2004
AXSYM CORTISOL ASSAY
Chemistry
84d