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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 -0243
Applicant Contact JUDITH J SMITH
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE,  MD  21030 -0243
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
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