FREND Testosterone Test System

Q: What is the product code of K153577?

The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.

FDA 510(k) K153577 · Nanoentek USA, Inc.

Substantially Equivalent

510(k) numberK153577

Submission

Device name: FREND Testosterone Test System
Applicant: Nanoentek USA, Inc.
Pleasanton, CA, US
Received: December 15, 2015
Decision date: October 14, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone
Device class: Class I (low risk)
Regulation: 21 CFR 862.1680
Specialty: Clinical Chemistry

Other 510(k)s with product code CDZ

510(k)	Device	Applicant	Decision
K252728	IDS-iSYS Total TestosteroneCDZ · Traditional	Immunodiagnostic Systems Limited	04/15/2026SE
K240865	IDS-iSYS Free TestosteroneCDZ · Traditional	Immunodiagnostic Systems Limited	10/23/2024SE
K233480	Access SHBGCDZ · Traditional	Beckman Coulter, Inc.	02/08/2024SE
K223405	Access TestosteroneCDZ · Traditional	Beckman Coulter, Inc.	01/13/2023SE
K211685	Elecsys Testosterone IICDZ · Traditional	Roche Diagnostics	05/06/2022SE
K201908	LIAISON Testosterone xtCDZ · Special	DiaSorin, Inc.	10/15/2020SE
K191350	ACTIVE® Free Testosterone RIACDZ · Special	Immunotech S.R.O.	12/20/2019SE
K191533	ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGCDZ · Traditional	Siemens Healthcare Diagnostics, Inc.	08/28/2019SE
K190121	Ids SHBGCDZ · Traditional	Immunodiagnostic Systems , Ltd.	06/17/2019SE
K182521	FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ · Traditional	Qualigen, Inc.	01/29/2019SE

More from Qualigen, Inc.

510(k)	Device	Decision
K162378	FREND PSA PLUS (reagent cartridge)LTJ · Traditional	05/17/2017SE
K162754	FREND Vitamin D Test SystemMRG · Traditional	01/12/2017SE
K152422	FREND Free T4 Test SystemCEC · Traditional	02/17/2016SE
K131928	Frend TSH (Reagent Cartridge)JLW · Traditional	03/14/2014SE

Questions and answers

When was FREND Testosterone Test System cleared by the FDA?

FREND Testosterone Test System (K153577) received a 510(k) decision of Substantially Equivalent on October 14, 2016, 304 days after the submission was received.

What is the product code of K153577?

The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.