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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 K123903
Device Name BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
Applicant
Becton, Dickinson & CO
7 Loveton Cir., Mc 614
Sparks,  MD  21152
Applicant Contact Paul Swift
Correspondent
Becton, Dickinson and Company
7 Loveton Circle Mc 694
Sparks,  MD  21152
Correspondent Contact Katherine Cicala
Regulation Number866.2560
Classification Product Code
MDB  
Date Received12/19/2012
Decision Date 05/13/2013
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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