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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 K232395
Device Name ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
Applicant
Biomérieux
376 Chemin De L'Orme
Marcy-L'Etoile,  FR 69280
Applicant Contact Sophie Quiblier
Correspondent
Biomérieux
376 Chemin De L'Orme
Marcy-L'Etoile,  FR 69280
Correspondent Contact Sophie Quiblier
Regulation Number866.1640
Classification Product Code
JWY  
Date Received08/09/2023
Decision Date 10/05/2023
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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