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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 K192738
Device Name ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
Applicant
BioMerieux SA
376, Chemin de L'Orme
Marcy L'Etoile,  FR 69280
Applicant Contact Sophie Quiblier
Correspondent
BioMerieux SA
376, Chemin de L'Orme
Marcy L'Etoile,  FR 69280
Correspondent Contact Sophie Quiblier
Regulation Number866.1640
Classification Product Code
JWY  
Date Received09/27/2019
Decision Date 11/26/2019
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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