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FDA 510(k)

Revogene

K-Number: K222779 · 2023-01-26

ApplicantMeridian Bioscience, Inc.
Decision Date2023-01-26
Product CodeOOI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Revogene is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K222779. 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 2023-01-26. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K222779.

When did Revogene receive FDA 510(k) clearance?

Revogene received FDA 510(k) clearance on 2023-01-26, under 510(k) number K222779.

Who is the listed applicant for Revogene?

The FDA 510(k) record lists Meridian Bioscience, 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 Meridian Bioscience, 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.

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Related Devices (Code: OOI)

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.

K243922RevogeneMeridian Bioscience, Inc.K220480RevogeneMeridian Bioscience, Inc.K170558revogeneGenepoc, Inc.K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)Luminex CorporationK160517ARIES SystemLuminex Corporation

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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