Product code NGA
- Device name
- Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1300
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809408864113 | Surearly SMART | Sugentech Inc._Osong Branch | 2026-05-08 |
| 06952062712688 | Follicle-Stimulating Hormone (FSH) Menopause test | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD | 2026-03-20 |
| 06952062712664 | Follicle-Stimulating Hormone (FSH) Menopause test | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD | 2026-03-20 |
| 00045611010055 | SURESIGN™ Menopause (FSH) Rapid Test | Guangzhou Decheng Biotechnology Co., LTD | 2026-01-28 |
| 50045611010050 | SURESIGN™ Menopause (FSH) Rapid Test | Guangzhou Decheng Biotechnology Co., LTD | 2026-01-28 |
| 20045611954018 | EPT Menopause (FSH) Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-12-10 |
| 50045611954019 | EPT Menopause (FSH) Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-12-10 |
| 06942598202340 | One Step FSH Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-10 |
| 06942598202333 | One Step FSH Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-10 |
| 06942598202326 | One Step FSH Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-10 |
| 00810038638072 | Easy@Home FSH Urine Test (5 Tests) | EASY HEALTHCARE CORPORATION | 2025-10-06 |
| 06936983131018 | One Step FSH Urine midstream Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-08-29 |
| 06936983131025 | One Step One Step FSH Urine test strip | Hangzhou AllTest Biotech Co., Ltd. | 2025-08-29 |
| 86936983131021 | One Step One Step FSH Urine test strip | Hangzhou AllTest Biotech Co., Ltd. | 2025-08-29 |
| 00850035206393 | Proov | Mfb Fertility, Inc. | 2025-08-15 |
| 00816862027242 | HORMONElife™ | WONDFO USA CO., LTD. | 2025-07-03 |
| 10816862027249 | HORMONElife™ | WONDFO USA CO., LTD. | 2025-07-03 |
| 08809408863475 | Surearly SMART Menopause Test | Sugentech Inc._Osong Branch | 2025-05-15 |
| 00816862026078 | Wondfo | WONDFO USA CO., LTD. | 2024-12-24 |
| 00860011489153 | Vivoo | VIVOSENS INC. | 2024-11-25 |
| 00816862024418 | BABYLife | WONDFO USA CO., LTD. | 2024-05-22 |
| 00633472602245 | Clearblue | SPD SWISS PRECISION DIAGNOSTICS GMBH | 2023-07-31 |
| 00810038634692 | One Step FSH Urine Test Strip(10 Tests) | EASY HEALTHCARE CORPORATION | 2023-07-19 |
| 00850035206164 | Proov | Mfb Fertility, Inc. | 2023-05-17 |
| 00850035206157 | Proov | Mfb Fertility, Inc. | 2023-05-17 |
| 00850035206065 | Proov | Mfb Fertility, Inc. | 2023-04-20 |
| 00850003500478 | Beurer | BEURER NORTH AMERICA, L.P. | 2021-10-01 |
| 10722066005337 | Rapid Response | BTNX Inc | 2021-06-24 |
| 00748349000700 | Be Sure | SYNTRON BIORESEARCH, INC. | 2020-07-17 |
| 00311917215754 | Walgreens | WALGREEN CO. | 2020-03-25 |