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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 K915330
Device Name DIRECTIGEN MENINGITIS COMBO TEST KIT
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact RUSSELL J.ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact RUSSELL J.ARNSBERGER
Regulation Number866.3390
Classification Product Code
GTJ  
Date Received11/26/1991
Decision Date 03/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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