Cleared Traditional

Access Cortisol

K223038 · Beckman Coulter, Inc. · Chemistry
Feb 2023
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K223038 is an FDA 510(k) clearance for the Access Cortisol, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on February 8, 2023, 132 days after receiving the submission on September 29, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K223038 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2022
Decision Date February 08, 2023
Days to Decision 132 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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