DRG Aurica Elisa Testosterone Kit

Q: What is the product code of K000043?

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) K000043 · Drg Intl., Inc.

Substantially Equivalent

510(k) numberK000043

Submission

Device name: DRG Aurica Elisa Testosterone Kit
Applicant: Drg Intl., Inc.
East Stroudsburg, PA, US
Received: January 6, 2000
Decision date: April 17, 2000
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
K062534	Enzyme Immunoassay for the Detection of Salivary 17-A-HYDROXYPROGESTERONEJLX · Traditional	01/29/2008SE
K052649	DRG SLV Testosterone Elisa TestCDZ · Traditional	01/27/2006SE
K051733	Enzyme Immunoassay for the Detection of Salivary CortisolNHG · Traditional	12/07/2005SE

Questions and answers

When was DRG Aurica Elisa Testosterone Kit cleared by the FDA?

DRG Aurica Elisa Testosterone Kit (K000043) received a 510(k) decision of Substantially Equivalent on April 17, 2000, 102 days after the submission was received.

What is the product code of K000043?

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