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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 K020813
Device Name BACT/ALERT FA CULTURE BOTTLE
Applicant
bioMerieux, Inc.
100 Rodolphe St.
Durham,  NC  27712
Applicant Contact RON SANYAL
Correspondent
bioMerieux, Inc.
100 Rodolphe St.
Durham,  NC  27712
Correspondent Contact RON SANYAL
Regulation Number866.2560
Classification Product Code
MDB  
Date Received03/13/2002
Decision Date 04/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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