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510(k) K153145

Lumipulse G TP-N Immunoreaction Cartridge Set by Fujirebio Diagnostics,Inc. — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2016
Date Received
October 30, 2015
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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