Cleared Traditional

Access OV Monitor

K240479 · Beckman Coulter, Inc. · Immunology
May 2024
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K240479 is an FDA 510(k) clearance for the Access OV Monitor, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 10, 2024, 80 days after receiving the submission on February 20, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K240479 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2024
Decision Date May 10, 2024
Days to Decision 80 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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