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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 K871620
Device Name ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT
Applicant
Allelix, Inc.
6850 Goreway Dr.
Mississauga, Ontario
Canada L4v 1p1,  CA
Applicant Contact JANET C SHAW
Correspondent
Allelix, Inc.
6850 Goreway Dr.
Mississauga, Ontario
Canada L4v 1p1,  CA
Correspondent Contact JANET C SHAW
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received04/27/1987
Decision Date 06/17/1987
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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