| Device Type ID | 358 |
| Device Name | Radioimmunoassay, Aldosterone |
| Regulation Description | Aldosterone Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1045 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CJM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 358 |
| Device | Radioimmunoassay, Aldosterone |
| Product Code | CJM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Aldosterone Test System. |
| CFR Regulation Number | 862.1045 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMMUNODIAGNOSTIC SYSTEMS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |