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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Antimicrobial Drug Removal
510(k) Number K830363
Device Name BACTEC 170 TRYPTIC SOY BROTH W/RESINS
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 Number866.2560
Classification Product Code
LJF  
Date Received02/04/1983
Decision Date 03/24/1983
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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