Access Testosterone— 510(k) K223405

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K223405 for Access Testosterone, Substantially Equivalent on 2023-01-13. Applicant: Beckman Coulter, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 2022-11-09
Decision date: 2023-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDZ

K252728 — IDS-iSYS Total Testosterone2026-04-15
K240865 — IDS-iSYS Free Testosterone2024-10-23
K233480 — Access SHBG2024-02-08
K211685 — Elecsys Testosterone II2022-05-06
K201908 — LIAISON Testosterone xt2020-10-15

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 K223405

K-number listed on FDA's recall record

Z-1901-2025 — Access Testosterone assay, Catalog Number 33560Class II·Ongoing·Beckman Coulter, Inc.·20250505

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223405.

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