IMMO PHASE DIRECT PROGESTERONE RADIO-
Device Facts
| Record ID | K830880 |
|---|---|
| Device Name | IMMO PHASE DIRECT PROGESTERONE RADIO- |
| Applicant | Corning Medical & Scientific |
| Product Code | JLS · Clinical Chemistry |
| Decision Date | Apr 18, 1983 |
| 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.
