Medical Device Manufacturer · US , North Caldwell , NJ

Fujirebio Diagnostics,Inc. - FDA 510(k) Cleared Devices

45 submissions · 43 cleared · Since 1989

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. Microbiology ✕

3 devices

1-3 of 3

Cleared Dec 10, 2017

Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G...

Microbiology · 93d

Cleared Jul 05, 2016

Lumipulse G TP-N Immunoreaction Cartridge Set

Microbiology · 249d

Cleared Nov 17, 1989

OLYMPUS PK(TM) TP

Microbiology · 206d