COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
Device Facts
| Record ID | K831178 |
|---|---|
| Device Name | COAT-A-COUNT NO-EXTRACTION ALDOSTERONE |
| Applicant | Diagnostic Products Corp. |
| Product Code | CJM · Clinical Chemistry |
| Decision Date | May 27, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1045 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
