CFA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electrode, Ion Specific, Magnesium
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1495
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MAGNESIUM PROCEDURE (K863267) | Data Medical Associates, Inc. | 1986-09-11 |
| ULTRA-VIOLET GLUCOSE REAGENT (K851514) | Bio-Analytics Laboratories, Inc. | 1985-05-20 |
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Every clearance here is in the API, with alerts when new ones post.