510(k) K223405

Device: Access Testosterone
Applicant: Beckman Coulter, Inc.
510(k) number: K223405
Product code: CDZ
Decision: Substantially Equivalent (SESE)
Decision date: 2023-01-13
Date received: 2022-11-09
Regulation: 862.1680
Classification name: Radioimmunoassay, Testosterones And Dihydrotestosterone
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K252728	IDS-iSYS Total Testosterone	Immunodiagnostic Systems Limited	2026-04-15
K240865	IDS-iSYS Free Testosterone	Immunodiagnostic Systems Limited	2024-10-23
K233480	Access SHBG	Beckman Coulter, Inc.	2024-02-08
K211685	Elecsys Testosterone II	Roche Diagnostics	2022-05-06
K201908	LIAISON Testosterone xt	DiaSorin, Inc.	2020-10-15
K191350	ACTIVE® Free Testosterone RIA	Immunotech S.R.O.	2019-12-20
K191533	ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG	Siemens Healthcare Diagnostics, Inc.	2019-08-28
K190121	IDS SHBG	Immunodiagnostic Systems , Ltd.	2019-06-17
K182521	FastPack IP Sex Hormone Binding Globulin Immunoassay	Qualigen, Inc.	2019-01-29
K181017	Free Testosterone AccuBind ELISA Test System	Monobind, Inc.	2018-07-20
K153577	FREND Testosterone Test System	Nanoentek USA, Inc.	2016-10-14
K151986	ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material	Siemens Healthcare Diagnostics, Inc.	2016-06-29
K151529	Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator	Siemens Healthcare Diagnostics, Inc.	2016-02-11
K152185	ARCHITECT SHBG	Biokit, S.A.	2016-02-11
K152155	ARCHITECT 2nd Generation Testosterone	Abbott Laboratories	2015-12-17