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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, Streptococcus Spp.
510(k) Number K860768
Device Name DIRECTIGEN COMBO MENINGITIS TEST
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Applicant Contact R. J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Correspondent Contact R. J ARNSBERGER
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received03/03/1986
Decision Date 05/13/1986
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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