| Device Type ID | 278 |
| Device Name | Electrode, Ion Specific, Magnesium |
| Regulation Description | Magnesium 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 | 862.1495 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CFA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 278 |
| Device | Electrode, Ion Specific, Magnesium |
| Product Code | CFA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Magnesium Test System. |
| CFR Regulation Number | 862.1495 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 5 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
| Total Device Problems | 10 |