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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K882300
Device Name SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030
Applicant Contact SCOTT K SMALLBROOK
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030
Correspondent Contact SCOTT K SMALLBROOK
Regulation Number866.1640
Classification Product Code
JWY  
Date Received06/02/1988
Decision Date 07/12/1988
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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