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510(k) K091361

IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM by Siemens Healthcare Diagnostics — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2009
Date Received
May 8, 2009
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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