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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 K183524
Device Name VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
Applicant
bioMerieux, Inc.
595 Anglum Road
Hazlewood,  MO  63042
Applicant Contact Esther Hernandez
Correspondent
bioMerieux, Inc.
595 Anglum Road
Hazlewood,  MO  63042
Correspondent Contact Esther Hernandez
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received12/19/2018
Decision Date 03/12/2019
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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