Access Cortisol— 510(k) K223038

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K223038 for Access Cortisol, Substantially Equivalent on 2023-02-08. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2022-09-29
Decision date: 2023-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGR

K242190 — Access Cortisol; DxC 500i Clinical Analyzer2025-03-05
K202136 — IDS Cortisol2021-04-13
K202826 — IMMULITE® 2000 Cortisol2021-01-15
K203270 — IMMULITE/IMMULITE® 1000 Cortisol2021-01-15
K062626 — CORTISOL ELISA2006-12-20

More clearances from Beckman Coulter, Inc.

K252169 — Access BNP II2026-03-24
K254059 — Access anti-HBc IgM2026-03-13
K253687 — Access anti-HBc Total2026-02-19
K251995 — Access anti-HAV IgM2026-01-27
K250588 — Access Rubella IgG2025-11-17

Recalls naming K223038

K-number listed on FDA's recall record

Z-0313-2025 — The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.Class II·Ongoing·Beckman Coulter, Inc.·20240930

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223038.

Data sourced from openFDA. This site is unofficial and independent of the FDA.