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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 K954924
Device Name BACTEC PEDS PLUS CLUTURE VIALS
Applicant
Becton Dickinson Diagnostic Instrument Systems
7loveton Cir.
Sparks,  MD  21152
Applicant Contact DAVID R MERTZ
Correspondent
Becton Dickinson Diagnostic Instrument Systems
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact DAVID R MERTZ
Regulation Number866.2560
Classification Product Code
MDB  
Date Received10/26/1995
Decision Date 02/08/1996
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
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