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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 Types, Streptococcus Pneumoniae
510(k) Number K884965
Device Name BACTIGEN(R) MENINGITIDIS PANEL
Applicant
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Applicant Contact ANN MACLEARIE
Correspondent
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Correspondent Contact ANN MACLEARIE
Regulation Number866.3740
Classification Product Code
GWC  
Date Received11/30/1988
Decision Date 02/07/1989
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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