Testosterone Direct Radioimmunoassay
FDA 510(k) K841948 · Sorin Biomedica, Fiat, USA, Inc.
510(k) numberK841948
Submission
- Device name
- Testosterone Direct Radioimmunoassay
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
Mchenry, IL, US - Received
- May 14, 1984
- Decision date
- June 25, 1984
- 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 |
|---|---|---|
| K931444 | Plexus 2 & 3.5 Hollow Fiber OxygenatorsDTZ · Traditional | 05/27/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | 05/18/1993SE |
| K925615 | Shiley Specialized,Pediatric & Neonatal Trach.TubeCBI · Traditional | 03/26/1993SE |
| K925369 | BCD Advanced Blood Carioplegia SystemsDTR · Traditional | 03/26/1993SE |
| K924354 | Stockert Caps Low Level Detect Ii/Bubble MonitorDTW · Traditional | 02/18/1993SE |
| K925541 | Stockert 1/4 Bubble SensorKRL · Traditional | 02/02/1993SE |
| K922933 | Sorin Monolyrh Integrated Membrane LungDTZ · Traditional | 11/30/1992SE |
| K854963 | S80 Implantable Cardiac Pacing LeadDTB · Traditional | 06/24/1986SE |
| K852641 | Orion 40 Cardiac Stimulator & PMP 200 ProgrammerDXY · Traditional | 01/14/1986SE |
| K851365 | Sorin Biomedica Orion 30/A Cardiac Stimulator & PMDXY · Traditional | 12/03/1985SE |
Questions and answers
When was Testosterone Direct Radioimmunoassay cleared by the FDA?
Testosterone Direct Radioimmunoassay (K841948) received a 510(k) decision of Substantially Equivalent on June 25, 1984, 42 days after the submission was received.
What is the product code of K841948?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.