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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 K970512
Device Name BACTEC MYCO/F LYTIC CULTURE VIALS
Applicant
Becton Dickinson Microbiology Systems
7loveton Cir.
Sparks,  MD  21152
Applicant Contact DENNIS R MERTZ
Correspondent
Becton Dickinson Microbiology Systems
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact DENNIS R MERTZ
Regulation Number866.2560
Classification Product Code
MDB  
Date Received02/11/1997
Decision Date 01/08/1998
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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