FDA Product Code
FDA Product Code CEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1665
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K043268 | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 | Randox Laboratories, Ltd. | 2005-02-15 | Traditional | PDF ↗ |
| K914039 | SODIUM REAGENT SET | Sterling Diagnostics, Inc. | 1991-10-31 | Traditional | PDF ↗ |
| K902572 | SODIUM REAGENT SET | Tech Intl. Co. | 1990-07-10 | Traditional | PDF ↗ |
| K832552 | SODIUM TEST KIT | Mallinckrodt Critical Care | 1983-09-20 | Traditional | PDF ↗ |
Product code CEI · Class II · Clinical Chemistry. Data: openFDA.