Medical Device Manufacturer · US , East Stroudsburg , PA

R-Biopharm AG - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2011

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - R-Biopharm AG Microbiology ✕

2 devices

1-2 of 2

Cleared Aug 21, 2017

RIDA GENE Norovirus GI/GII

Microbiology · 89d

Not Cleared Feb 23, 2011

RIDASCREEN NOROVIRUS 3RD GENERATION EIA

DEN110001 · OUC

Microbiology · 7d