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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Enriched
510(k) Number K854064
Device Name BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.2330
Classification Product Code
KZI  
Date Received10/04/1985
Decision Date 10/23/1985
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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