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510(k) K153730

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control by Abbott Laboratories — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2016
Date Received
December 28, 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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