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510(k) K050590

ENZY-WELL SYPHILIS IGG, MODEL 91106 by Diesse Diagnostica Senese S.P.A. — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2006
Date Received
March 8, 2005
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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