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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 K220480
Device Name Revogene
Applicant
Meridian Bioscience, Inc
3471 River Hills Drive
Cincinnati,  OH  45244
Applicant Contact Jack Rogers
Correspondent
Meridian Bioscience, Inc
3471 River Hills Drive
Cincinnati,  OH  45244
Correspondent Contact Jack Rogers
Regulation Number862.2570
Classification Product Code
OOI  
Date Received02/18/2022
Decision Date 07/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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