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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, All Groups, N. Meningitidis
510(k) Number K920274
Device Name DIRECTIGEN NEISSERIA MENINGITIDIS TEST
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030 -0243
Applicant Contact ROBERT E JAMES
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030 -0243
Correspondent Contact ROBERT E JAMES
Regulation Number866.3390
Classification Product Code
GTI  
Date Received01/22/1992
Decision Date 03/18/1992
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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