CJM — Radioimmunoassay, Aldosterone Class II
FDA product code CJM covers "Radioimmunoassay, Aldosterone", a Class II medical device regulated under 21 CFR 862.1045. Submissions are reviewed by the Clinical Chemistry panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CJM
- Device Class
- Class II
- Regulation Number
- 862.1045
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142994 | immunodiagnostic systems | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone | April 21, 2015 |
| K130321 | diasorin | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBR | April 9, 2013 |
| K050784 | nichols institute diagnostics | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | June 1, 2005 |
| K032188 | nichols institute diagnostics | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | July 31, 2003 |
| K943397 | diagnostic systems laboratories | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | February 13, 1995 |
| K921205 | diagnostic systems laboratories | DSL ACTIVE ALDOSTERONE (DSL 8600) | July 10, 1992 |
| K862204 | radioassay systems laboratories | RSL (125I) ALDOSTERONE KIT | September 25, 1986 |
| K834428 | serono laboratories | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | March 2, 1984 |
| K831178 | diagnostic products | COAT-A-COUNT NO-EXTRACTION ALDOSTERONE | May 27, 1983 |
| K800775 | sorin biomedica, fiat, usa | ALDOCTK-125 | April 21, 1980 |
| K781504 | abbott laboratories | 125I-ALDOSTERONE RIA DIAG. KIT | November 22, 1978 |
| K771526 | diagnostic products | 125 I ALDOSTERONE RIA KIT | August 25, 1977 |