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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
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