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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 K946268
Device Name BACTEC(R) 9000TB SYSTEM
Applicant
Becton Dickinson Diagnostic Instrument Systems
7 Loveton Circle
Sparks,  MD  21152 -0999
Applicant Contact DENNIS R MERTZ
Correspondent
Becton Dickinson Diagnostic Instrument Systems
7 Loveton Circle
Sparks,  MD  21152 -0999
Correspondent Contact DENNIS R MERTZ
Regulation Number866.2560
Classification Product Code
MDB  
Date Received12/23/1994
Decision Date 05/21/1996
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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