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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Platelet
510(k) Number K770655
Device Name LATELET DETERMIBATION KIT, UL 800
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 Number864.8625
Classification Product Code
GJP  
Date Received04/06/1977
Decision Date 06/24/1977
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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