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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Staphylococcus Aureus
510(k) Number K821962
Device Name BBL STAPHYSLIDE 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 Number866.2660
Classification Product Code
JWX  
Date Received07/01/1982
Decision Date 07/30/1982
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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