(125I) Testosterone Kit
FDA 510(k) K791999 · Radioassay Systems Laboratories, Inc.
510(k) numberK791999
Submission
- Device name
- (125I) Testosterone Kit
- Applicant
- Radioassay Systems Laboratories, Inc.
Mchenry, IL, US - Received
- October 5, 1979
- Decision date
- October 30, 1979
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K862204 | RSL (125I) Aldosterone KitCJM · Traditional | 09/25/1986SE |
| K842960 | Androstenedione by RiaCIZ · Traditional | 09/27/1984SE |
| K840886 | Hydroxyprogesterone by Ria 17AJLS · Traditional | 04/18/1984SE |
| K831855 | Hatch KitCKG · Traditional | 07/28/1983SE |
| K802195 | Dehydroepiandrosterone Sulfate Kit RiaJKC · Traditional | 10/23/1980SE |
| K800126 | RSL (125 L) Progesterone KitJLS · Traditional | 02/13/1980SE |
| K791835 | Coralent Coat 125I Cortisol Radioimm.CGR · Traditional | 09/27/1979SE |
| K791740 | Serum 11-DESOXYCORTISOL I AS TracerJKB · Traditional | 09/27/1979SE |
| K791728 | Rsl's Assay Procedure QuantitationCGI · Traditional | 09/27/1979SE |
| K791652 | Estradiol Kit by RiaCHP · Traditional | 09/27/1979SE |
Questions and answers
When was (125I) Testosterone Kit cleared by the FDA?
(125I) Testosterone Kit (K791999) received a 510(k) decision of Substantially Equivalent on October 30, 1979, 25 days after the submission was received.
What is the product code of K791999?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.