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510(k) K093837

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

K093837 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. (Zeus) for the device "ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 2010. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830.

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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FDA data resources