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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Real Time Nucleic Acid Amplification System
510(k) Number K222779
Device Name Revogene
Applicant
Meridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact Jack Rogers
Correspondent
Meridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact Jack Rogers
Regulation Number862.2570
Classification Product Code
OOI  
Date Received09/14/2022
Decision Date 01/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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