CEI
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Uranyl Acetate/Zinc Acetate, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 (K043268) | Randox Laboratories, Ltd. | 2005-02-15 |
| SODIUM REAGENT SET (K914039) | Sterling Diagnostics, Inc. | 1991-10-31 |
| SODIUM REAGENT SET (K902572) | Tech Intl. Co. | 1990-07-10 |
| SODIUM TEST KIT (K832552) | Mallinckrodt Critical Care | 1983-09-20 |
Track CEI automatically
Every clearance here is in the API, with alerts when new ones post.