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FDA 510(k)

BIOGENNIX RPC

K-Number: K093342 · 2010-07-29

ApplicantBiogennix, LLC
Decision Date2010-07-29
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOGENNIX RPC is the device name listed in this FDA 510(k) record. The listed applicant is Biogennix, LLC. It received FDA 510(k) clearance on 2010-07-29 under 510(k) number K093342. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGENNIX RPC?

BIOGENNIX RPC is a medical device that received FDA 510(k) clearance on 2010-07-29. The listed applicant is Biogennix, LLC. The 510(k) number is K093342.

When did BIOGENNIX RPC receive FDA 510(k) clearance?

BIOGENNIX RPC received FDA 510(k) clearance on 2010-07-29, under 510(k) number K093342.

Who is the listed applicant for BIOGENNIX RPC?

The FDA 510(k) record lists Biogennix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOGENNIX RPC?

The FDA product code for BIOGENNIX RPC is MQV.

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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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