Fujirebio Diagnostics,Inc. - FDA 510(k) Cleared Devices
Recent clearances: ADVIA Centaur Cytokeratin Fragment 21-1, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, Lumipulse G CA15-3
45
Total
43
Cleared
1
Denied
FDA 510(k) Regulatory Record - 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