Cleared Traditional

Access Cortisol; DxC 500i Clinical Analyzer

K242190 · Beckman Coulter, Inc. · Chemistry
Mar 2025
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K242190 is an FDA 510(k) clearance for the Access Cortisol; DxC 500i Clinical Analyzer, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on March 5, 2025, 223 days after receiving the submission on July 25, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K242190 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2024
Decision Date March 05, 2025
Days to Decision 223 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGR — Radioimmunoassay, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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