Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K150022
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream · Guangzhou Wondfo Biotech Co., Ltd. · decided 2015-08-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VeriQuick | 11012450MB | FOURSTAR GROUP INC. | LCX | 00049696737746 |
| HORMONElife™ | H1-M-E10-1BX | WONDFO USA CO., LTD. | LCX | 00816862027747 |
| Modern Fertility Pregnancy Test | A | MODERN HEALTH | LCX | 00860000599610 |
| Preview | PRE-HCG-OTC-10-3BX-CA | WONDFO USA CO., LTD. | LCX | 00816862024241 |
| Modern Fertility Pregnancy Test | 1 | MODERN HEALTH | LCX | 00860000599689 |
| Wondfo | DW1-S10-25BX-CA | WONDFO USA CO., LTD. | LCX | 00816862026986 |
| Family Wellness | 0903756 | FOURSTAR GROUP INC. | LCX | 00032251056192 |
| HORMONElife™ | H1-S-E10-25BX-CLIA | WONDFO USA CO., LTD. | JHI | 00816862027723 |
| Wondfo | W1-S10 | WONDFO USA CO., LTD. | JHI LCX | 00816862021516 |
| VeriQuick | 11012450MA | FOURSTAR GROUP INC. | LCX | 00049696737739 |
| Preview | PRE-HCG-25SE-CLIA | WONDFO USA CO., LTD. | JHI | 00816862023787 |
| Modern Fertility Pregnancy Test | A | MODERN HEALTH | LCX | 00860000599634 |
| Stix | 1 | Get Stix Inc. | LCX | 00860002060408 |
| Modern Fertility Pregnancy Test | 1 | MODERN HEALTH | LCX | 00850029375203 |
| Preview | HCG-PRE-OTC10 | WONDFO USA CO., LTD. | JHI LCX | 00816862022179 |
| Family Wellness | 0939504 | FOURSTAR GROUP INC. | LCX | 00032251057663 |
| Wondfo | DW1-S10-25BX-B | WONDFO USA CO., LTD. | LCX | 00816862024043 |
| Modern Fertility Pregnancy Test | 1 | MODERN HEALTH | LCX | 00850029375029 |
| Modern Fertility Pregnancy Test | 1 | MODERN HEALTH | LCX | 00860000599696 |