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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
510(k) Number K162385
Device Name RAPIDEC CARBA NP
Applicant
BIOMERIEUX SA
5 RUE DES AQUEDUCS
CRAPONNE,  FR 69290
Applicant Contact ASA KARLSSON
Correspondent
BIOMERIEUX SA
5 RUE DES AQUEDUCS
CRAPONNE,  FR 69290
Correspondent Contact ASA KARLSSON
Regulation Number866.1640
Classification Product Code
PTJ  
Date Received08/25/2016
Decision Date 04/27/2017
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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