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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 K760588
Device Name IMPROVED THAYER MARTIN MEDIUM
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number866.2410
Classification Product Code
JTY  
Date Received09/03/1976
Decision Date 10/07/1976
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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