HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
Device Facts
| Record ID | K011323 |
|---|---|
| Device Name | HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 |
| Applicant | Salimetrics, LLC |
| Product Code | NHG · Clinical Chemistry |
| Decision Date | Dec 17, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1205 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
