Cleared Traditional

VITROS Immuodiagnostic Products CA 125 II Reagent Pack

K221355 · Ortho-Clinical Diagnostics · Immunology
Dec 2022
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K221355 is an FDA 510(k) clearance for the VITROS Immuodiagnostic Products CA 125 II Reagent Pack, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on December 12, 2022, 216 days after receiving the submission on May 10, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K221355 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2022
Decision Date December 12, 2022
Days to Decision 216 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LTK — Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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