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 |