Matched Component Set Radioimmunoassay
FDA 510(k) K841042 · Cambridge Medical Technology
510(k) numberK841042
Submission
- Device name
- Matched Component Set Radioimmunoassay
- Applicant
- Cambridge Medical Technology
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- April 19, 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 |
|---|---|---|
| K890837 | Ria-Gnost InsulinCFP · Traditional | 04/26/1989SE |
| K890836 | Ria-Gnost ProgesteroneJLS · Traditional | 03/16/1989SE |
| K890697 | Ria-Gnost FerritinJMG · Traditional | 03/16/1989SE |
| K873737 | No Spin(Tm) T3 Coated Tube RadioimmunoassayCDP · Traditional | 11/24/1987SE |
| K870573 | T4 No Spin(Tm) Coated Tube Radioimmunoassay KitCDX · Traditional | 04/22/1987SE |
| K862871 | Radioimmunoassay of No Spin(Tm) CortisolCGR · Traditional | 08/19/1986SE |
| K860130 | Testosterone Coated Tubes Radioimmunoassay KitCDZ · Traditional | 02/19/1986SE |
| K855169 | T3 Uptake Radioimmunoassay KitKHQ · Traditional | 02/06/1986SE |
| K850254 | Parathyroid Hormone Radioimmunoassay KitCEW · Traditional | 04/03/1985SE |
| K843635 | Matched Component Set for Radioimmuno-JKC · Traditional | 09/28/1984SE |
Questions and answers
When was Matched Component Set Radioimmunoassay cleared by the FDA?
Matched Component Set Radioimmunoassay (K841042) received a 510(k) decision of Substantially Equivalent on April 19, 1984, 38 days after the submission was received.
What is the product code of K841042?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.