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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuge, Hematocrit
510(k) Number K813033
Device Name CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
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 Number864.6400
Classification Product Code
GKG  
Date Received10/28/1981
Decision Date 04/09/1982
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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