510(k) K171511
- Device
- RIDA GENE Norovirus GI/GII
- Applicant
- R-Biopharm AG
- 510(k) number
- K171511
- Product code
- PIQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-21
- Date received
- 2017-05-24
- Regulation
- 866.3990
- Classification name
- Reagents For Detection Of Norovirus Nucleic Acid
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Andreas Simons
- Address
- An Der Neuen Bergstrabe 17 Darmstadt DE 64297 64297
FDA Registration Numbers#
- 2029372
- 3004061467
- 3016548670
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary