DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
Device Facts
| Record ID | K943397 |
|---|---|
| Device Name | DSL ACTIVE ALDOSTERONE RIA (DSL 8600) |
| Applicant | Diagnostic Systems Laboratories, Inc. |
| Product Code | CJM · Clinical Chemistry |
| Decision Date | Feb 13, 1995 |
| 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.
