INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY
Device Facts
| Record ID | K955390 |
|---|---|
| Device Name | INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY |
| Applicant | Corning Nichols Diagnostics |
| Product Code | CFL · Clinical Chemistry |
| Decision Date | Dec 29, 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.
