125 I PROLACTIN HORMONE RIA KIT
Device Facts
| Record ID | K792166 |
|---|---|
| Device Name | 125 I PROLACTIN HORMONE RIA KIT |
| Applicant | Diagnostic Products Corp. |
| Product Code | CFT · Clinical Chemistry |
| Decision Date | Nov 13, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1625 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
