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510(k) K042731

ARCHITECT CA 125 II ASSAY by Fujirebio Diagnostics,Inc. — Product Code LTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2004
Date Received
October 1, 2004
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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