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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 K122359
Device Name VITEK 2 STRPTOCOCCUS CEFTRIAXONE
Applicant
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Applicant Contact THI MY LAN DANG
Correspondent
BIOMERIEUX, INC.
595 ANGLUM RD.
HAZELWOOD,  MO  63042
Correspondent Contact THI MY LAN DANG
Regulation Number866.1645
Classification Product Code
LON  
Date Received08/03/2012
Decision Date 08/28/2012
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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