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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, Non-Propagating Transport
510(k) Number K854986
Device Name BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
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 Number866.2390
Classification Product Code
JSM  
Date Received12/12/1985
Decision Date 01/03/1986
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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