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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K830646
Device Name DIRECTIGEN NEISSERIA MENINGITIDIS
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
Date Received03/01/1983
Decision Date 05/27/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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