MZU · System, Test, Sodium, Enzymatic Method
Clinical Chemistry · 21 CFR 862.1665 · Class 2
Overview
| Product Code | MZU |
|---|---|
| Device Name | System, Test, Sodium, Enzymatic Method |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K082763 | DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B | Diazyme Laboratories | Nov 12, 2008 | SESE |
| K042189 | DIAZYME SODIUM ENZYMATIC ASSAY | Diazyme Laboratories | Oct 7, 2004 | SESE |
Top Applicants
- Diazyme Laboratories — 2 clearances
