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510(k) K061247

DIASORIN LIAISON TREPONEMA ASSAY by DiaSorin, Inc. — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2006
Date Received
May 3, 2006
Clearance Type
Traditional
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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