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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, N. Meningitidis
510(k) Number K952791
Device Name DIRECTIGEN MENINGITIS COMBO TEST
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030
Applicant Contact JUDITH J SMITH
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 243
Cockeysville,  MD  21030
Correspondent Contact JUDITH J SMITH
Regulation Number866.3390
Classification Product Code
GTJ  
Date Received06/19/1995
Decision Date 05/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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