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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 K831887
Device Name BACTIGEN S. PNEUMONIAE
Applicant
Armkel, LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Armkel, LLC
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3740
Classification Product Code
GWC  
Date Received06/13/1983
Decision Date 09/26/1983
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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