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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 Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
510(k) Number K033105
Device Name CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
Applicant
Trinity Biotech USA
2823 Girts Rd.
Jamestown,  NY  14701
Applicant Contact BONNIE DEJOY
Correspondent
Trinity Biotech USA
2823 Girts Rd.
Jamestown,  NY  14701
Correspondent Contact BONNIE DEJOY
Regulation Number866.3305
Classification Product Code
MXJ  
Date Received09/30/2003
Decision Date 07/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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