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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, B Lymphocyte Marker
510(k) Number K851639
Device Name ANTI-LEU-12 B CELL REAGENT
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Applicant Contact RUSSELL J ARNSBERGE
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent Contact RUSSELL J ARNSBERGE
Regulation Number864.5220
Classification Product Code
LJD  
Date Received04/19/1985
Decision Date 07/02/1986
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
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