Nordiclab Testosterone Ria Test
FDA 510(k) K800921 · Nordiclab Intl.
510(k) numberK800921
Submission
- Device name
- Nordiclab Testosterone Ria Test
- Applicant
- Nordiclab Intl.
Walker, MI, US - Received
- April 21, 1980
- Decision date
- May 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K801988 | Nordiclab Prostatic Acid Phosphatase RiaJFH · Traditional | 09/26/1980SE |
| K801989 | Nordiclab Ferritin Irma TestDBF · Traditional | 09/16/1980SE |
| K800922 | Nordiclab Progesterone Ria TestJLS · Traditional | 05/14/1980SE |
| K800920 | Nordiclab Estradiol Ria TestCHP · Traditional | 05/14/1980SE |
| K792189 | Nordiclab Total Estriol Ria TestCGI · Traditional | 11/13/1979SE |
| K782157 | Irma Test, Nordiclab FerritinJMG · Traditional | 01/17/1979SE |
| K782099 | Ria Test, Nordicalb HPLJMF · Traditional | 01/10/1979SE |
Questions and answers
When was Nordiclab Testosterone Ria Test cleared by the FDA?
Nordiclab Testosterone Ria Test (K800921) received a 510(k) decision of Substantially Equivalent on May 14, 1980, 23 days after the submission was received.
What is the product code of K800921?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.