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510(k) K221355

VITROS Immuodiagnostic Products CA 125 II Reagent Pack by Ortho Clinical Diagnostics — Product Code LTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2022
Date Received
May 10, 2022
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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