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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
Original Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood,  MO  63042
Original Contact thi my lan dang
Regulation Number866.1645
Classification Product Code
LON  
Date Received08/03/2012
Decision Date 08/28/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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