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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Ha (Including Ha Control), Rubella
510(k) Number K800797
Device Name MACRO-VUE RUBELLA CARD TEST
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 Number866.3510
Classification Product Code
GOL  
Date Received04/09/1980
Decision Date 06/20/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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