510(k) DEN110001
- Device
- RIDASCREEN NOROVIRUS 3RD GENERATION EIA
- Applicant
- R-Biopharm AG
- 510(k) number
- DEN110001
- Product code
- OUC
- Decision
- Unknown (DENG)
- Decision date
- 2011-02-23
- Date received
- 2011-02-16
- Regulation
- 866.3395
- Classification name
- Norovirus Serological Reagent
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gary Lehnus
- Address
- 150 Cherry Ln. Rd. East Stroudsburg PA US 18301 18301
FDA Registration Numbers#
- 3014150341
- 2029372
- 3005360469
- 3016548670
- 3024463179
Source Documents#
510(k) summary PDF not indicated by FDA