Fujirebio Diagnostics,Inc. - FDA 510(k) Cleared Devices
45
Total
43
Cleared
1
Denied
Fujirebio Diagnostics,Inc. has 43 FDA 510(k) cleared medical devices. Based in North Caldwell, US.
Latest FDA clearance: Dec 2025. Active since 1989. Primary specialty: Immunology.
Browse the FDA 510(k) cleared devices submitted by Fujirebio Diagnostics,Inc. Filter by specialty or product code using the sidebar.
45 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
Aug 24, 2020
ST AIA-PACK BNP
Chemistry
360d
Cleared
May 14, 2020
Lumipulse G CA19-9-N
Immunology
28d
Cleared
Aug 30, 2019
Lumipulse G whole PTH
Chemistry
165d
Cleared
Dec 10, 2017
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G...
Microbiology
93d
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
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