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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 K812315
Device Name BACTEC RESIN CULTURE MED. 16A
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number866.2560
Classification Product Code
MDB  
Date Received08/17/1981
Decision Date 11/10/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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