Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K252550
SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx · Guangzhou Wondfo Biotech Co., Ltd. · decided 2025-11-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SAFElife™ | CDOA-6135F | WONDFO USA CO., LTD. | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028348 |
| SAFElife™ | TDOA-6135F | WONDFO USA CO., LTD. | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028362 |
| SAFElife™ | CDOA-L11135A3 | WONDFO USA CO., LTD. | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028294 |
| SAFElife™ | CDOA-L11145 | WONDFO USA CO., LTD. | LCM NFT NFV NFW NFY NGG NGL PTG PTH QAW | 00816862028027 |
| SAFElife™ | CDOA-12135NT | WONDFO USA CO., LTD. | LCM NFT NFV NFY NGG NGL PTG PTH QAW | 00816862028249 |
| SAFElife™ | CDOA-L11135A3 | WONDFO USA CO., LTD. | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028089 |
| Prime Screen® | DCDOA-L964-5BX-A | WONDFO USA CO., LTD. | LCM NFT NFW NFY NGL | 00810174471229 |
| SAFElife™ | CDOA-L13145NT | WONDFO USA CO., LTD. | LCM NFT NFV NFW NFY NGG NGL PTG PTH | 00816862028713 |