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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 K880665
Device Name MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
Applicant
Allelix Diagnostics, Inc.
6850 Goreway Dr.
Mississauga, Ontario
Canada L4v 1p1,  CA
Applicant Contact JANET SHAW
Correspondent
Allelix Diagnostics, Inc.
6850 Goreway Dr.
Mississauga, Ontario
Canada L4v 1p1,  CA
Correspondent Contact JANET SHAW
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received02/18/1988
Decision Date 03/01/1988
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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