LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION
Device Facts
| Record ID | K904458 |
|---|---|
| Device Name | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION |
| Applicant | London Diagnostics, Inc. |
| Product Code | CFT · Clinical Chemistry |
| Decision Date | Oct 12, 1990 |
| 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.
