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510(k) K102400

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

K102400 is an FDA 510(k) premarket notification submitted by Diagnostics Direct, LLC for the device "SYPHILIS HEALTH CHECK". The FDA issued a decision of Substantially Equivalent on August 1, 2011. 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
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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FDA data resources