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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
510(k) Number K014233
Device Name CAPTIAM SYPHILIS-G ASSAY
Applicant
Trinity Biotech, Plc
Ida Business Park Bray
Co. Wicklow,  IE
Applicant Contact FIONA CAMPBELL
Correspondent
Trinity Biotech, Plc
Ida Business Park Bray
Co. Wicklow,  IE
Correspondent Contact FIONA CAMPBELL
Regulation Number866.3830
Classification Product Code
LIP  
Date Received12/26/2001
Decision Date 01/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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