DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
Device Facts
| Record ID | K950228 |
|---|---|
| Device Name | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) |
| Applicant | Diagnostic Systems Laboratories, Inc. |
| Product Code | CFL · Clinical Chemistry |
| Decision Date | Feb 22, 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.
