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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Study, Platelet Adhesive
510(k) Number K771523
Device Name LATELET RETENTION COLUMN
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number864.6650
Classification Product Code
JBZ  
Date Received08/08/1977
Decision Date 11/22/1977
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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