Fujirebio Diagnostics,Inc. - FDA 510(k) Cleared Devices
45
Total
43
Cleared
1
Denied
FDA 510(k) cleared devices by Fujirebio Diagnostics,Inc. Immunology ✕
20 devices
Cleared
Dec 16, 2025
ADVIA Centaur Cytokeratin Fragment 21-1
Immunology
264d
Cleared
May 16, 2025
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
Immunology
249d
Not Cleared
May 04, 2022
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
Immunology
530d
Cleared
Sep 04, 2020
Lumipulse G CA15-3
Immunology
357d
Cleared
May 14, 2020
Lumipulse G CA19-9-N
Immunology
28d
Cleared
May 16, 2016
Lumipulse G ROMA
Immunology
122d
Cleared
Apr 28, 2016
ARCHITECT ROMA
Immunology
329d
Cleared
Nov 24, 2015
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
Immunology
186d
Cleared
May 21, 2015
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges,...
Immunology
230d
Cleared
Sep 01, 2011
ROMA (HE4 EIA + ARCHITECT CA 125 II)
Immunology
289d
Cleared
Jul 19, 2011
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
Immunology
215d
Cleared
May 26, 2011
CYFRA 21-1 EIA MODEL 211-10
Immunology
428d
Cleared
Oct 05, 2010
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
Immunology
98d
Cleared
Mar 18, 2010
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS...
Immunology
85d
Cleared
Jun 09, 2008
HE4 EIA, MODEL: 404-10 US
Immunology
236d
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
May 09, 2002
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
Immunology
78d