Guangzhou Decheng Biotechnology Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Guangzhou Decheng Biotechnology Co., Ltd.” (first 2022, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 105 days. Since 2017 the median was 105 days, against 110 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 121 |
| 2023 | 2 | 78 |
| 2024 | 2 | 82 |
| 2025 | 3 | 159 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangzhou Decheng Biotechnology Co., Ltd. took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 4 | 4 |
| DJG | Enzyme Immunoassay, Opiates | 2 | 2 |
| NGL | Test, Opiates, Over The Counter | 2 | 2 |
Review panels
Most recent Guangzhou Decheng Biotechnology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | LCX | 2025-09-09 | 159 |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | NGL | 2025-02-20 | 41 |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | NGL | 2025-02-06 | 175 |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | LCX | 2024-06-21 | 106 |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | DJG | 2024-05-10 | 57 |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | DJG | 2023-12-13 | 104 |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | LCX | 2023-02-28 | 53 |
| K222305 | MissLan Digital Pregnancy Rapid Test | LCX | 2022-11-30 | 121 |
Recalls
openFDA lists no recalls under a recalling firm named Guangzhou Decheng Biotechnology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Guangzhou Wondfo Biotech Co., Ltd. (43 510(k)s)
- Guangzhou Xinbo Electronic Co., Ltd. (12 510(k)s)
- Guangzhou Red Pine Medical Instrument Co., Ltd. (10 510(k)s)
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (7 510(k)s)
- Guangzhou Berrcom Medical Device Co., Ltd. (6 510(k)s)
- Guangzhou Longest Science & Technology Co., Ltd. (6 510(k)s)
- Guangzhou Heygears IMC., Inc. (4 510(k)s)
- Guangzhou Ajax Medical Equipment Co., Ltd. (3 510(k)s)
- Guangzhou Finecure Medical Equipment Co.,Ltd (3 510(k)s)
- Guangzhou Longest Medical Technology Co., Ltd. (3 510(k)s)
- Guangzhou Sonostar Technologies Co., Ltd. (3 510(k)s)
- Guangzhou Chemicals Import & Export Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangzhou Decheng Biotechnology Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Guangzhou Decheng Biotechnology Co., Ltd.” (first 2022, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Guangzhou Decheng Biotechnology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangzhou Decheng Biotechnology Co., Ltd. is 105 days. Since 2017: 105 days, versus 110 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangzhou Decheng Biotechnology Co., Ltd.?
The most frequent FDA product codes under this applicant name are LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 4); DJG (Enzyme Immunoassay, Opiates, 2); NGL (Test, Opiates, Over The Counter, 2).
Next steps
- See all 8 Guangzhou Decheng Biotechnology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LCX, Guangzhou Decheng Biotechnology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.