RIDA GENE Norovirus GI/GII— 510(k) K171511
Substantially EquivalentR-Biopharm AG
FDA 510(k) clearance K171511 for RIDA GENE Norovirus GI/GII, Substantially Equivalent on 2017-08-21. Applicant: R-Biopharm AG. Device class: 2.
Clearance details
- Applicant
- R-Biopharm AG
- Product code
- Code PIQ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3990
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Darmstadt, DE
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