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510(k) K014233

CAPTIAM SYPHILIS-G ASSAY by Trinity Biotech, Plc — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2002
Date Received
December 26, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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