SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
Device Facts
| Record ID | K914886 |
|---|---|
| Device Name | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) |
| Applicant | Serono-Baker Diagnostics, Inc. |
| Product Code | CGR · Clinical Chemistry |
| Decision Date | Mar 2, 1992 |
| 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.
