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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 K163006
Device Name VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
Applicant
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Jennifer Jines
Correspondent
bioMerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Jennifer Jines
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
LTT   LTW  
Date Received10/28/2016
Decision Date 01/24/2017
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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