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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 K121461
Device Name BACT/ALERT FA PLUS CULTURE BOTTLE
Original Applicant
BIOMERIEUX, INC.
100 rodolphe st
durham,  NC  27712
Original Contact jocelyn jennings
Regulation Number866.2560
Classification Product Code
MDB  
Date Received05/17/2012
Decision Date 01/22/2013
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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