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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K982373
Device Name UNI-GOLD STREP A TEST KIT
Applicant
Trinity Biotech, Plc
575 Shirlynn Ct.
Los Angeles,  CA  94022
Applicant Contact Erika B Ammirati
Correspondent
Trinity Biotech, Plc
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact Erika B Ammirati
Regulation Number866.3740
Classification Product Code
GTY  
Date Received07/07/1998
Decision Date 02/11/1999
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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