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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, blood culturing
510(K) Number K121455
Device Name BACT/ALERT FN PLUS CULTURE BOTTLE
Applicant
BIOMERIEUX, INC.
100 rodolphe st
durham,  NC  27712
Contact patricia murphy
Regulation Number866.2560
Classification Product Code
MDB  
Date Received05/16/2012
Decision Date 01/25/2013
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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