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510(k) K093837

ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM by Zeus Scientific, Inc. (Zeus) — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2010
Date Received
December 15, 2009
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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