Company · CN
Guangzhou Decheng Biotechnology Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2025 | K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test Guangzhou Decheng Biotechnology Co., Ltd., CN | LCX |
| Feb 20, 2025 | K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro Guangzhou Decheng Biotechnology Co., Ltd., CN | NGL |
| Feb 6, 2025 | K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fen Guangzhou Decheng Biotechnology Co., Ltd., CN | NGL |
| Jun 21, 2024 | K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detectio Guangzhou Decheng Biotechnology Co., Ltd., CN | LCX |
| May 10, 2024 | K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard Guangzhou Decheng Biotechnology Co., Ltd., CN | DJG |
| Dec 13, 2023 | K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup Guangzhou Decheng Biotechnology Co., Ltd., CN | DJG |
| Feb 28, 2023 | K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) Guangzhou Decheng Biotechnology Co., Ltd., CN | LCX |
| Nov 30, 2022 | K222305 | MissLan Digital Pregnancy Rapid Test Guangzhou Decheng Biotechnology Co., Ltd., CN | LCX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||