Product code CJM
- Device name
- Radioimmunoassay, Aldosterone
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1045
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2015-04-21 |
| K130321 | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS | Diasorin | 2013-04-09 |
| K050784 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Nichols Institute Diagnostics | 2005-06-01 |
| K032188 | NICHOLS ADVANTAGE ALDOSTERONE ASSAY | Nichols Institute Diagnostics | 2003-07-31 |
| K943397 | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) | Diagnostic Systems Laboratories, Inc. | 1995-02-13 |
| K921205 | DSL ACTIVE ALDOSTERONE (DSL 8600) | Diagnostic Systems Laboratories, Inc. | 1992-07-10 |
| K862204 | RSL (125I) ALDOSTERONE KIT | Radioassay Systems Laboratories, Inc. | 1986-09-25 |
| K834428 | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT | Serono Laboratories, Inc. | 1984-03-02 |
| K831178 | COAT-A-COUNT NO-EXTRACTION ALDOSTERONE | Diagnostic Products Corp. | 1983-05-27 |
| K800775 | ALDOCTK-125 | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 |
| K781504 | 125I-ALDOSTERONE RIA DIAG. KIT | Abbott Laboratories | 1978-11-22 |
| K771526 | 125 I ALDOSTERONE RIA KIT | Diagnostic Products Corp. | 1977-08-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816870023854 | Aldosterone AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023861 | Aldosterone AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024769 | Aldosterone AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024776 | Aldosterone AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00817830022269 | Aldosterone Double Antibody 125I RIA Kit | MP BIOMEDICALS, LLC | 2016-10-20 |
| 15099590211592 | ACTIVE Aldosterone RIA | IMMUNOTECH s.r.o. | 2016-09-09 |
| 05060169690363 | IDS-iSYS Aldosterone | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2016-04-01 |