Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

revogene

K-Number: K170558 · 2017-05-25

ApplicantGenepoc, Inc.
Decision Date2017-05-25
Product CodeOOI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

revogene is a medical device manufactured by Genepoc, Inc.. It received FDA 510(k) clearance on 2017-05-25 under approval 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. It is manufactured by Genepoc, Inc.. The 510(k) number is K170558.

When was revogene approved by the FDA?

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

What company makes revogene?

revogene is manufactured by Genepoc, Inc..

What is the FDA product code for revogene?

The FDA product code for revogene is OOI.

Other Devices by Genepoc, Inc.

K172569GenePOC CDiff K170557GenePOC GBS LB K190275GenePOC Carba K183366GenePOC Strep A

Related Devices (Code: OOI)

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 K220480RevogeneMeridian Bioscience, Inc. K222779RevogeneMeridian Bioscience, Inc. K243922RevogeneMeridian Bioscience, Inc.

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.

↑