Cleared Traditional

Elecsys CA-125 II assay

K143534 · Roche Professional Diagnostics · Immunology
Aug 2015
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K143534 is an FDA 510(k) clearance for the Elecsys CA-125 II assay, a Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (Class II — Special Controls, product code LTK), submitted by Roche Professional Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on August 6, 2015, 237 days after receiving the submission on December 12, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K143534 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2014
Decision Date August 06, 2015
Days to Decision 237 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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