COAT-A-COUNT LH IRMA
Device Facts
| Record ID | K951748 |
|---|---|
| Device Name | COAT-A-COUNT LH IRMA |
| Applicant | Diagnostic Products Corp. |
| Product Code | CEP · Clinical Chemistry |
| Decision Date | May 15, 1995 |
| 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.
