Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangzhou Decheng Biotechnology Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
175 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Ea | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-09-09 | 159 | 0 |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-20 | 41 | 0 |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Te | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-06 | 175 | 0 |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Earl | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-06-21 | 106 | 0 |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 | 57 | 0 |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Uri | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-12-13 | 104 | 0 |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Ra | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-02-28 | 53 | 0 |
| K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2022-11-30 | 121 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda