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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, automated, antimicrobial susceptibility, short incubation
510(k) Number K191766
Device Name VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
Applicant
bioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Applicant Contact Esther Hernandez
Correspondent
bioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Correspondent Contact Esther Hernandez
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received07/01/2019
Decision Date 08/05/2019
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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