COBAS CORE LH EIA
Device Facts
| Record ID | K930306 |
|---|---|
| Device Name | COBAS CORE LH EIA |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | CEP · Clinical Chemistry |
| Decision Date | May 26, 1993 |
| 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.
