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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 Cards, Antimicrobial
510(k) Number K844231
Device Name SCEPTOR BETA-LACTAM PLUS MIC PANEL
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Applicant Contact RUSSELL J ARNSBERGE
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent Contact RUSSELL J ARNSBERGE
Regulation Number866.1640
Classification Product Code
LTW  
Date Received10/30/1984
Decision Date 11/07/1984
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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