AURAFLEX PROGESTERONE 150TEST PACK
Device Facts
| Record ID | K951630 |
|---|---|
| Device Name | AURAFLEX PROGESTERONE 150TEST PACK |
| Applicant | Organon Teknika Corp. |
| Product Code | JLS · Clinical Chemistry |
| Decision Date | May 8, 1995 |
| 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.
