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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 K954923
Device Name BACTEC FUNGAL MEDIUM
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
JTA  
Date Received10/26/1995
Decision Date 11/21/1996
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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