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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Automated Blood Grouping And Antibody
510(k) Number K770185
Device Name RH CONTROL DILUENT
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 Number864.9175
Classification Product Code
KSZ  
Date Received01/27/1977
Decision Date 03/14/1977
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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