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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 K951542
Device Name DIRECTIGEN 1-2-3 GROUP A STREP TEST
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 987
Columbus,  NE  68602
Applicant Contact JUDITH J SMITH
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 987
Columbus,  NE  68602
Correspondent Contact JUDITH J SMITH
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received04/03/1995
Decision Date 10/20/1995
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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