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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 K192050
Device Name ETEST Eravacycline (ERV) (0.002 – 32 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 Received07/31/2019
Decision Date 09/27/2019
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
Recalls CDRH Recalls
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