Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K183097
Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream · Weihai Kangzhou Biotechnology Engineering Co., Ltd. · decided 2019-01-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| INSTANT Aid By PUR-est | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600032 |
| Oichid | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600070 |
| Universal | cassette | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304621112 |
| MaYa | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600087 |
| FERTICARE | strip | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX NGE | 06923304611151 |
| CLARISSE | Test midstream I | DELTA BRANDS INC. | LCX | 00808829125672 |
| Clarisse | Midstream | DELTA BRANDS INC. | LCX | 00808829120615 |
| PERSONAL CARE | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600018 |
| SUPER-AID | Cassette | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304621129 |
| FERTICARE | STRIP | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600100 |
| Walgreens | 116420 | WALGREEN CO. | CEP LCX | 00311917207087 |
| FERTICARE | Strip | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600056 |
| ZIOXX | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600049 |
| Sims pregnancy test kit | cassette | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600094 |
| FERTICARE | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600063 |
| kangzhou | Cassette | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304621136 |
| SUPER-AID | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600025 |
| FERTICARE | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600131 |
| FERTICARE | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600124 |
| FERTICARE | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600186 |
| FERTICARE | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600162 |
| FERTICARE | midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600155 |
| U Pregnancy Test | Cassette | Weihai Kangzhou Biotechnology Engineering Co., Ltd | LCX | 06923304600193 |