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510(k) K080561

VIDAS CA 125 II ASSAY by bioMerieux, Inc. — Product Code LTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2009
Date Received
February 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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