RIDASCREEN NOROVIRUS 3RD GENERATION EIA
FDA 510(k) clearance DEN110001 · decided 2011-02-23
Clearance details
- K-number
- DEN110001
- Device name
- RIDASCREEN NOROVIRUS 3RD GENERATION EIA
- Applicant
- R-Biopharm AG
- Decision
- Unknown
- Date received
- 2011-02-16
- Decision date
- 2011-02-23
- Days to decision
- 7 days
- Clearance type
- Post-NSE
- Product code
- OUC
- Device class
- 2
- Regulation number
- 866.3395
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- East Stroudsburg, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.