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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 K950123
Device Name SCEPTOR SYSTEM PANELS
Applicant
Becton Dickinson Microbiology Systems
250 Schilling Cir.
Sparks,  MD  21030
Applicant Contact JUDITH J SMITH
Correspondent
Becton Dickinson Microbiology Systems
250 Schilling Cir.
Sparks,  MD  21030
Correspondent Contact JUDITH J SMITH
Regulation Number866.1640
Classification Product Code
JWY  
Date Received01/12/1995
Decision Date 03/23/1995
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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