RIDA GENE Norovirus GI/GII
FDA 510(k) clearance K171511 · decided 2017-08-21
Clearance details
- K-number
- K171511
- Device name
- RIDA GENE Norovirus GI/GII
- Applicant
- R-Biopharm AG
- Decision
- Substantially Equivalent
- Date received
- 2017-05-24
- Decision date
- 2017-08-21
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- PIQ
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Darmstadt, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.