LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
Device Facts
| Record ID | K894279 |
|---|---|
| Device Name | LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | CEP · Clinical Chemistry |
| Decision Date | Aug 15, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1485 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.
