Cleared Traditional

VITROS Immunodiagnostic Products CEA Reagent Pack

K231517 · Ortho-Clinical Diagnostics · Immunology
Aug 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K231517 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products CEA Reagent Pack, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on August 23, 2023, 90 days after receiving the submission on May 25, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K231517 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2023
Decision Date August 23, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHX — System, Test, Carcinoembryonic Antigen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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