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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K912480
Device Name BBL(R) DMACA INDOLE REAGENT DROPPERS
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number866.2660
Classification Product Code
JTO  
Date Received06/03/1991
Decision Date 08/23/1991
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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