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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 K031737
Device Name BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
Applicant
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Applicant Contact JOCELYN JENNINGS
Correspondent
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Correspondent Contact JOCELYN JENNINGS
Regulation Number866.2560
Classification Product Code
MDB  
Date Received06/04/2003
Decision Date 07/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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