SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
Device Facts
| Record ID | K895380 |
|---|---|
| Device Name | SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY |
| Applicant | Serono-Baker Diagnostics, Inc. |
| Product Code | CFT · Clinical Chemistry |
| Decision Date | Oct 17, 1989 |
| 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.
