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
K171511 · PIQ
Microbiology · 89d
Not Cleared Feb 23, 2011
RIDASCREEN NOROVIRUS 3RD GENERATION EIA
DEN110001 · OUC
Microbiology · 7d
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