The following data is part of a premarket notification filed by R-biopharm Ag with the FDA for Rida Gene Norovirus Gi/gii.
| Device ID | K171511 |
| 510k Number | K171511 |
| Device Name: | RIDA GENE Norovirus GI/GII |
| Classification | Reagents For Detection Of Norovirus Nucleic Acid |
| Applicant | R-Biopharm AG An Der Neuen Bergstrabe 17 Darmstadt, DE 64297 |
| Contact | Andreas Simons |
| Correspondent | Patricia Meinhardt R-Biopharm Inc 870 Vossbrink Drive Washington, MO 63090 |
| Product Code | PIQ |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-24 |
| Decision Date | 2017-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049095160356 | K171511 | 000 |