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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lymphocyte separation medium
510(k) Number K854093
Device Name LEUCO PREP
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 Number864.8500
Classification Product Code
JCF  
Date Received10/07/1985
Decision Date 11/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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