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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 K200512
Device Name ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
Applicant
bioMérieux S.A.
376 Chemin de l'Orme
Marcy L'Etoile,  FR 69280
Applicant Contact Alexia Bosquet
Correspondent
bioMérieux S.A.
376 Chemin de l'Orme
Marcy L'Etoile,  FR 69280
Correspondent Contact Alexia Bosquet
Regulation Number866.1640
Classification Product Code
JWY  
Date Received03/02/2020
Decision Date 05/07/2020
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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