Uranyl Acetate/Zinc Acetate, Sodium
The Uranyl Acetate/Zinc Acetate Sodium Test is a clinical chemistry device that measures sodium concentration in biological fluids using a precipitation reaction with uranyl acetate and zinc acetate, forming an insoluble complex proportional to the sodium content, used in the evaluation of electrolyte balance and disorders such as hyponatremia and hypernatremia. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CEI, regulated under 21 CFR 862.1665, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CEI
- Device Class
- FDA class 2
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K043268 | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 | Feb 15, 2005 | Substantially Equivalent | Randox Laboratories, Ltd. |
| K914039 | SODIUM REAGENT SET | Oct 31, 1991 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K902572 | SODIUM REAGENT SET | Jul 10, 1990 | Substantially Equivalent | Tech Intl. Co. |
| K832552 | SODIUM TEST KIT | Sep 20, 1983 | Substantially Equivalent | Mallinckrodt Critical Care |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.