CEI — Uranyl Acetate/Zinc Acetate, Sodium Class II
FDA product code CEI covers "Uranyl Acetate/Zinc Acetate, Sodium", a Class II medical device regulated under 21 CFR 862.1665. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CEI
- Device Class
- Class II
- Regulation Number
- 862.1665
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K043268 | randox laboratories | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 | February 15, 2005 |
| K914039 | sterling diagnostics | SODIUM REAGENT SET | October 31, 1991 |
| K902572 | tech intl | SODIUM REAGENT SET | July 10, 1990 |
| K832552 | mallinckrodt critical care | SODIUM TEST KIT | September 20, 1983 |