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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 K911731
Device Name LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number864.8500
Classification Product Code
JCF  
Date Received04/17/1991
Decision Date 12/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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