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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 S.A.
376 Chemin De L’Orme
Marcy L'Etoile,  FR 69280
Applicant Contact Marine Taravant
Correspondent
Biomerieux S.A.
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
Predetermined Change
Control Plan Authorized		 No
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