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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 K112075
Device Name VITEK 2 STRPTOCOCCUS AMPICILLIN
Original Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood,  MO  63042
Original Contact jolyn tenllado
Regulation Number866.1645
Classification Product Code
LON  
Date Received07/20/2011
Decision Date 09/15/2011
Decision substantially equivalent (SE)
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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