NGA · Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Clinical Chemistry · 21 CFR 862.1300 · Class 1
Overview
| Product Code | NGA |
|---|---|
| Device Name | Test, Follicle Stimulating Hormone (Fsh), Over The Counter |
| Regulation | 21 CFR 862.1300 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070484 | QUANTRX FEMALE FERTILITY TEST | Quantrx Biomedical Corporation | Oct 22, 2007 | SESE |
| K032002 | FERTELL FEMALE FERTILITY TEST | Genosis, Inc. | Oct 30, 2003 | SESE |
Top Applicants
- Genosis, Inc. — 1 clearance
- Quantrx Biomedical Corporation — 1 clearance
