FDA 510(k)

revogene

K-Number: K170558 · 2017-05-25

Decision Date2017-05-25

Product CodeOOI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

revogene is the device name listed in this FDA 510(k) record. The listed applicant is Genepoc, Inc.. It received FDA 510(k) clearance on 2017-05-25 under 510(k) number K170558. The device is classified under product code OOI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the revogene?

revogene is a medical device that received FDA 510(k) clearance on 2017-05-25. The listed applicant is Genepoc, Inc.. The 510(k) number is K170558.

When did revogene receive FDA 510(k) clearance?

revogene received FDA 510(k) clearance on 2017-05-25, under 510(k) number K170558.

Who is the listed applicant for revogene?

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

What is the FDA product code for revogene?

The FDA product code for revogene is OOI.

Other records listing Genepoc, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190275GenePOC Carba K183366GenePOC Strep A K172569GenePOC CDiff K170557GenePOC GBS LB

Related Devices (Code: OOI)

K243922RevogeneMeridian Bioscience, Inc.K222779RevogeneMeridian Bioscience, Inc.K220480RevogeneMeridian Bioscience, Inc.K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)Luminex Corporation K160517ARIES SystemLuminex Corporation

Official Source

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