Testosterone by Enzymeimmunoassay (Eia)
FDA 510(k) K014120 · Diagnostics Biochem Canada, Inc.
510(k) numberK014120
Submission
- Device name
- Testosterone by Enzymeimmunoassay (Eia)
- Applicant
- Diagnostics Biochem Canada, Inc.
London, Ontario, CA - Received
- December 17, 2001
- Decision date
- February 8, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K030730 | Free Testosterone Enzymeimmunoassay (Eia) KitCDZ · Traditional | 08/18/2003SE |
| K864966 | Estrone Analysis Products Radioimmunoassay EstroneCGF · Traditional | 01/09/1987SE |
| K832297 | HYDROXYPROGESTERONE-17JLS · Traditional | 09/01/1983SE |
| K801729 | Androstenedione Radioimmunoassay KitCIZ · Traditional | 10/31/1980SE |
| K781310 | Human Chorionic Gonado.-Beta Ria KitJHI · Traditional | 08/31/1978SE |
Questions and answers
When was Testosterone by Enzymeimmunoassay (Eia) cleared by the FDA?
Testosterone by Enzymeimmunoassay (Eia) (K014120) received a 510(k) decision of Substantially Equivalent on February 8, 2002, 53 days after the submission was received.
What is the product code of K014120?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.