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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 K161217
Device Name VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
Applicant
bioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Applicant Contact Karen Russell
Correspondent
bioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Correspondent Contact Karen Russell
Regulation Number866.1645
Classification Product Code
LON  
Date Received04/29/2016
Decision Date 01/12/2017
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
Recalls CDRH Recalls
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