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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Direct Agglutination Test, Toxoplasma Gondii
510(k) Number K831930
Device Name TOXO-SCREEN DA 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 Number866.3780
Classification Product Code
LLA  
Date Received06/15/1983
Decision Date 09/26/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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