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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 K001525
Device Name CAPTIA SYPHILIS-G ELISA TEST SYSTEM
Applicant
Trinity Biotech, Plc
P.O. Box 1059, 2823 Girts Rd.
Jamestown,  NY  14702
Applicant Contact WAYNE KVETKOSKY
Correspondent
Trinity Biotech, Plc
P.O. Box 1059, 2823 Girts Rd.
Jamestown,  NY  14702
Correspondent Contact WAYNE KVETKOSKY
Regulation Number866.3830
Classification Product Code
LIP  
Date Received05/16/2000
Decision Date 11/29/2000
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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