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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
Applicant Contact PATRICIA MURPHY
Correspondent
bioMerieux, Inc.
100 Rodolphe St.
Durham,  NC  27712
Correspondent Contact PATRICIA MURPHY
Regulation Number866.2560
Classification Product Code
MDB  
Date Received05/16/2012
Decision Date 01/25/2013
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
Predetermined Change
Control Plan Authorized		 No
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