17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
Device Facts
| Record ID | K885198 |
|---|---|
| Device Name | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA |
| Applicant | Icn Biomedicals, Inc. |
| Product Code | JLX · Clinical Chemistry |
| Decision Date | Feb 23, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1395 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.
