Radioimmunoassay, Aldosterone
FDA product code CJM · Class II (moderate risk) · 21 CFR 862.1045 · Clinical Chemistry
12510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 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 |
| K862204 | RSL (125I) Aldosterone KitCJM · Traditional | Radioassay Systems Laboratories, Inc. | 09/25/1986SE |
| 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 |
| K771526 | 125 I Aldosterone Ria KitCJM · Traditional | Diagnostic Products Corp. | 08/25/1977SE |