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

Cleared Aug 24, 2020

ST AIA-PACK BNP

K192380 · NBC

Chemistry · 360d

Cleared Aug 30, 2019

Lumipulse G whole PTH

K190702 · CEW

Chemistry · 165d

Cleared Jul 28, 2017

Lumipulse G TSH-III Immunoreaction Cartridges

K171103 · JLW

Chemistry · 106d

Cleared Jan 13, 2017

Lumipulse G FSH-N Calibrators

K163534 · JIT

Chemistry · 28d

Cleared Jan 13, 2017

Lumipulse G Progesterone-N Calibrators

K163546 · JIT

Chemistry · 28d

Cleared Jan 12, 2017

Lumipulse G LH Calibrators

K163521 · JIT

Chemistry · 28d

Cleared Jan 12, 2017

Lumipulse G Prolactin

K163544 · JIT

Chemistry · 27d

Cleared Dec 01, 2016

Lumipulse G E2-III Calibrators

K163053 · JIT

Chemistry · 30d

Cleared Apr 15, 2016

Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

K153361 · MRG

Chemistry · 147d

Cleared Dec 23, 2014

ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT...

K140436 · OSX

Chemistry · 305d

Cleared Jan 17, 2014

FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE

K133197 · JJX

Chemistry · 92d

Cleared Jan 17, 2013

FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

K123612 · JJX

Chemistry · 55d