Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K251053
Shinetell PlusTM Digital Early Pregnancy Test · Hangzhou AllTest Biotech Co., Ltd. · decided 2025-07-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Shinetell Plus Digital Pregnancy Test | 1 | Hangzhou AllTest Biotech Co., Ltd. | LCX | 06936983197991 |
| Shinetell Plus Digital Pregnancy Test | 1 | Hangzhou AllTest Biotech Co., Ltd. | LCX | 06936983198004 |
| Shinetell Plus Digital Pregnancy Test | 1 | Hangzhou AllTest Biotech Co., Ltd. | LCX | 06936983197984 |
| Shinetell Plus Digital Pregnancy Test | 1 | Hangzhou AllTest Biotech Co., Ltd. | LCX | 06936983198011 |
| Atida DIGITAL EARLY PREGNANCY TEST | EKA02ST-HCG-US | ACESO LABORATORIES INC. | LCX | 00810164510709 |