ACTIVE IGF-I ELISA
Device Facts
| Record ID | K951752 |
|---|---|
| Device Name | ACTIVE IGF-I ELISA |
| Applicant | Diagnostic Systems Laboratories, Inc. |
| Product Code | CFL · Clinical Chemistry |
| Decision Date | May 10, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1370 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.
