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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, For Isolation Of Pathogenic Neisseria
510(k) Number K864078
Device Name MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1880
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.2410
Classification Product Code
JTY  
Date Received10/20/1986
Decision Date 10/31/1986
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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