NGA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1300
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QUANTRX FEMALE FERTILITY TEST (K070484) | Quantrx Biomedical Corporation | 2007-10-22 |
| FERTELL FEMALE FERTILITY TEST (K032002) | Genosis, Inc. | 2003-10-30 |
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Every clearance here is in the API, with alerts when new ones post.