Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

45 results for "Fujirebio Diagnostics,Inc."
1–24 of 45
Cleared Dec 16, 2025
ADVIA Centaur Cytokeratin Fragment 21-1
K250925 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 264d
Cleared May 16, 2025
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
K242706 · SET
Fujirebio Diagnostics,Inc.
Immunology · 249d
Not Cleared May 04, 2022
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
DEN200072 · QSE
Fujirebio Diagnostics,Inc.
Immunology · 530d
Cleared Sep 04, 2020
Lumipulse G CA15-3
K192524 · MOI
Fujirebio Diagnostics,Inc.
Immunology · 357d
Cleared Aug 24, 2020
ST AIA-PACK BNP
K192380 · NBC
Fujirebio Diagnostics,Inc.
Chemistry · 360d
Cleared May 14, 2020
Lumipulse G CA19-9-N
K200997 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 28d
Cleared Aug 30, 2019
Lumipulse G whole PTH
K190702 · CEW
Fujirebio Diagnostics,Inc.
Chemistry · 165d
Cleared Dec 10, 2017
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G...
K172713 · PRI
Fujirebio Diagnostics,Inc.
Microbiology · 93d
Cleared Jul 28, 2017
Lumipulse G TSH-III Immunoreaction Cartridges
K171103 · JLW
Fujirebio Diagnostics,Inc.
Chemistry · 106d
Cleared Jan 13, 2017
Lumipulse G Progesterone-N Calibrators
K163546 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 13, 2017
Lumipulse G FSH-N Calibrators
K163534 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 12, 2017
Lumipulse G Prolactin
K163544 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 27d
Cleared Jan 12, 2017
Lumipulse G LH Calibrators
K163521 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Dec 01, 2016
Lumipulse G E2-III Calibrators
K163053 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 30d
Cleared Jul 05, 2016
Lumipulse G TP-N Immunoreaction Cartridge Set
K153145 · LIP
Fujirebio Diagnostics,Inc.
Microbiology · 249d
Cleared May 16, 2016
Lumipulse G ROMA
K160090 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 122d
Cleared Apr 28, 2016
ARCHITECT ROMA
K151502 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 329d
Cleared Apr 15, 2016
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
K153361 · MRG
Fujirebio Diagnostics,Inc.
Chemistry · 147d
Cleared Nov 24, 2015
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
K151378 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 186d
Cleared May 21, 2015
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges,...
K142895 · LTK
Fujirebio Diagnostics,Inc.
Immunology · 230d
Cleared Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT...
K140436 · OSX
Fujirebio Diagnostics,Inc.
Chemistry · 305d
Cleared Jan 17, 2014
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
K133197 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 92d
Cleared Jan 17, 2013
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
K123612 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 55d
Cleared Sep 01, 2011
ROMA (HE4 EIA + ARCHITECT CA 125 II)
K103358 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 289d