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FDA 510(k)

RIDA GENE Norovirus GI/GII

K-Number: K171511 · 2017-08-21

ApplicantR-Biopharm AG
Decision Date2017-08-21
Product CodePIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RIDA GENE Norovirus GI/GII is the device name listed in this FDA 510(k) record. The listed applicant is R-Biopharm AG. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171511. The device is classified under product code PIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIDA GENE Norovirus GI/GII?

RIDA GENE Norovirus GI/GII is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is R-Biopharm AG. The 510(k) number is K171511.

When did RIDA GENE Norovirus GI/GII receive FDA 510(k) clearance?

RIDA GENE Norovirus GI/GII received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171511.

Who is the listed applicant for RIDA GENE Norovirus GI/GII?

The FDA 510(k) record lists R-Biopharm AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIDA GENE Norovirus GI/GII?

The FDA product code for RIDA GENE Norovirus GI/GII is PIQ.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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