CEI · Uranyl Acetate/Zinc Acetate, Sodium
Clinical Chemistry · 21 CFR 862.1665 · Class 2
Overview
| Product Code | CEI |
|---|---|
| Device Name | Uranyl Acetate/Zinc Acetate, Sodium |
| Regulation | 21 CFR 862.1665 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Classification Rationale
Class II.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K043268 | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 | Randox Laboratories, Ltd. | Feb 15, 2005 | SESE |
| K914039 | SODIUM REAGENT SET | Sterling Diagnostics, Inc. | Oct 31, 1991 | SESE |
| K902572 | SODIUM REAGENT SET | Tech Intl. Co. | Jul 10, 1990 | SESE |
| K832552 | SODIUM TEST KIT | Mallinckrodt Critical Care | Sep 20, 1983 | SESE |
Top Applicants
- Mallinckrodt Critical Care — 1 clearance
- Randox Laboratories, Ltd. — 1 clearance
- Sterling Diagnostics, Inc. — 1 clearance
- Tech Intl. Co. — 1 clearance
