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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 K011709
Device Name UNI-GOLD STREP A TEST KIT
Applicant
Trinity Biotech, Plc
Ida Business Park
Ballinasloe,  IE
Applicant Contact FIONA CAMPBELL
Correspondent
Trinity Biotech, Plc
Ida Business Park
Ballinasloe,  IE
Correspondent Contact FIONA CAMPBELL
Regulation Number866.3740
Classification Product Code
GTZ  
Subsequent Product Code
GTY  
Date Received06/04/2001
Decision Date 11/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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