VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
Device Facts
| Record ID | K964720 |
|---|---|
| Device Name | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | CGJ · Clinical Chemistry |
| Decision Date | Feb 4, 1997 |
| 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.
