RSL (125I) Aldosterone Kit
FDA 510(k) K862204 · Radioassay Systems Laboratories, Inc.
510(k) numberK862204
Submission
- Device name
- RSL (125I) Aldosterone Kit
- Applicant
- Radioassay Systems Laboratories, Inc.
Carson, CA, US - Received
- June 10, 1986
- Decision date
- September 25, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJM – Radioimmunoassay, Aldosterone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1045
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…CJM · Traditional | Immunodiagnostic Systems , Ltd. | 04/21/2015SE |
| K130321 | Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…CJM · Traditional | Diasorin | 04/09/2013SE |
| K050784 | Nichols Advantage Aldosterone AssayCJM · Traditional | Nichols Institute Diagnostics | 06/01/2005SE |
| K032188 | Nichols Advantage Aldosterone AssayCJM · Traditional | Nichols Institute Diagnostics | 07/31/2003SE |
| K943397 | DSL Active Aldosterone Ria (DSL 8600)CJM · Traditional | Diagnostic Systems Laboratories, Inc. | 02/13/1995SE |
| K921205 | DSL Active Aldosterone (DSL 8600)CJM · Traditional | Diagnostic Systems Laboratories, Inc. | 07/10/1992SE |
| K834428 | Aldosterone Radioimmunoassay Test KitCJM · Traditional | Serono Laboratories, Inc. | 03/02/1984SE |
| K831178 | Coat-A-Count No-Extraction AldosteroneCJM · Traditional | Diagnostic Products Corp. | 05/27/1983SE |
| K800775 | ALDOCTK-125CJM · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 04/21/1980SE |
| K781504 | 125I-ALDOSTERONE Ria Diag. KitCJM · Traditional | Abbott Laboratories | 11/22/1978SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K791999 | (125I) Testosterone KitCDZ · Traditional | 10/30/1979SE |
| 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 RSL (125I) Aldosterone Kit cleared by the FDA?
RSL (125I) Aldosterone Kit (K862204) received a 510(k) decision of Substantially Equivalent on September 25, 1986, 107 days after the submission was received.
What is the product code of K862204?
The FDA product code is CJM – Radioimmunoassay, Aldosterone, a Class II (moderate risk) device regulated under 21 CFR 862.1045.