TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
Device Facts
| Record ID | K870520 |
|---|---|
| Device Name | TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY |
| Applicant | Hybritech, Inc. |
| Product Code | CGJ · Clinical Chemistry |
| Decision Date | Mar 10, 1987 |
| 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.
