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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Hai (Including Hai Control), Rubella
510(k) Number K832228
Device Name RUBASCAN LATEX 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
GOK  
Date Received07/11/1983
Decision Date 09/29/1983
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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