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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K843713
Device Name DIRECTIGEN GROUP A STREP TEST KIT
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received09/21/1984
Decision Date 01/04/1985
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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