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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Microbial Growth
510(k) Number K792575
Device Name BACTEC BACTERIAL DETECTION SYSTEM
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
JTA  
Date Received12/13/1979
Decision Date 12/27/1979
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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