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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 K210757
Device Name ETEST Fosfomycin (FO) (0.032-512 µg/mL)
Applicant
bioMerieux SA
376, chemin de l’Orme
Marcy-l’Etoile,  FR 69280
Applicant Contact Marine Taravant
Correspondent
bioMerieux SA
376, chemin de l’Orme
Marcy-l’Etoile,  FR 69280
Correspondent Contact Marine Taravant
Regulation Number866.1640
Classification Product Code
JWY  
Date Received03/15/2021
Decision Date 11/12/2021
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
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