PROGESTERONE SYSTEM BY EIA
Device Facts
| Record ID | K864156 |
|---|---|
| Device Name | PROGESTERONE SYSTEM BY EIA |
| Applicant | Intl. Bioclinical, Inc. |
| Product Code | JLS · Clinical Chemistry |
| Decision Date | Nov 24, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1620 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
