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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K260447
Device Name ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
Applicant
bioMérieux SA
376 Chemin De L'Orme
Marcy-L'Etoile,  FR 69280
Applicant Contact Stéphanie Millon-Serme
Correspondent
Biomérieux
376 Chemin De L'Orme
Marcy-L'Etoile,  FR 69280
Correspondent Contact Stéphanie Millon-Serme
Regulation Number866.1640
Classification Product Code
JWY  
Date Received02/11/2026
Decision Date 04/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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