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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bacillus Subtilis, Microbiological Assay, Gentamicin
510(k) Number K760942
Device Name GENTASAK
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 Number862.3450
Classification Product Code
DKD  
Date Received11/01/1976
Decision Date 03/07/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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