Medical Device Manufacturer · US , North Caldwell , NJ

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

45 submissions · 43 cleared · Since 1989

45

Total

43

Cleared

1

Denied

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

3 devices

1-3 of 3

Cleared Sep 11, 2008

ARCHITECT CYCLOSPORINE

Toxicology · 177d

Cleared Sep 28, 2007

ARCHITECT SIROLIMUS ASSAY

Toxicology · 186d

Cleared Aug 01, 2007

ARCHITECT TACROLIMUS: MODEL 1L77

Toxicology · 128d