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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, blood culturing
510(k) Number K190405
Device Name BACT/ALERT MP Reagent System
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 Number866.2560
Classification Product Code
MDB  
Date Received02/19/2019
Decision Date 05/15/2019
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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