Revogene
K-Number: K243922 · 2025-03-20
ApplicantMeridian Bioscience, Inc.
Decision Date2025-03-20
Product CodeOOI
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Revogene is a medical device manufactured by Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2025-03-20 under approval number K243922. 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 2025-03-20. It is manufactured by Meridian Bioscience, Inc.. The 510(k) number is K243922.
When was Revogene approved by the FDA?
Revogene received FDA 510(k) clearance on 2025-03-20, under approval number K243922.
What company makes Revogene?
Revogene is manufactured by Meridian Bioscience, Inc..
What is the FDA product code for Revogene?
The FDA product code for Revogene is OOI.
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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.