IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
Device Facts
| Record ID | K883745 |
|---|---|
| Device Name | IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES |
| Applicant | Diagnostic Products Corp. |
| Product Code | CGJ · Clinical Chemistry |
| Decision Date | Nov 30, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.
