COTUBE LH IRMA ASSAY
Device Facts
| Record ID | K884498 |
|---|---|
| Device Name | COTUBE LH IRMA ASSAY |
| Applicant | Bio-Rad |
| Product Code | CEP · Clinical Chemistry |
| Decision Date | Dec 22, 1988 |
| 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.
