PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM
Device Facts
| Record ID | K952075 |
|---|---|
| Device Name | PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM |
| Applicant | Bayer Corp. |
| Product Code | JLS · Clinical Chemistry |
| Decision Date | Jun 13, 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.
