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510(k) K063866

BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM by Bio-Rad Laboratories — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2007
Date Received
December 29, 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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  • K102400 — SYPHILIS HEALTH CHECK (August 1, 2011)