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.
FDA 510(k) cleared devices by Fujirebio Diagnostics,Inc.
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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