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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K850358
Device Name CEFTRIAXONE 30 MCG SENSI-DISC
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.1620
Classification Product Code
JTN  
Date Received01/30/1985
Decision Date 03/20/1985
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
Recalls CDRH Recalls
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