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510(k) K102400

SYPHILIS HEALTH CHECK by Diagnostics Direct, LLC — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2011
Date Received
August 24, 2010
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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