Guangzhou Wondfo Biotech Co., Ltd.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Guangzhou Wondfo Biotech Co., Ltd.” (first 2005, latest 2026), across 20 product codes in 4 review panels. Median 510(k) review time under this name: 61 days. Since 2017 the median was 109 days, against 122 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 |
|---|---|---|
| 2012 | 6 | 58 |
| 2013 | 5 | 36 |
| 2014 | 6 | 72 |
| 2015 | 6 | 29 |
| 2016 | 1 | 59 |
| 2017 | 1 | 265 |
| 2018 | 2 | 113 |
| 2019 | 0 | — |
| 2020 | 1 | 21 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 86 |
| 2025 | 2 | 138 |
| 2026 | 1 | 109 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangzhou Wondfo Biotech Co., Ltd. took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 8 | 8 |
| DKZ | Enzyme Immunoassay, Amphetamine | 6 | 6 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 | 4 |
| NFT | Test, Amphetamine, Over The Counter | 4 | 4 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 3 | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 | 2 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
Plus 10 more product codes.
Review panels
- Clinical Toxicology (35)
- Clinical Chemistry (4)
- Microbiology (3)
- Hematology (1)
Most recent Guangzhou Wondfo Biotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | NFT | 2026-04-28 | 109 |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | NFT | 2025-11-18 | 97 |
| K251289 | WELLlife COVID-19 Antigen Test Rx | QVF | 2025-10-22 | 180 |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | QYT | 2024-09-30 | 143 |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel | NGL | 2024-07-16 | 29 |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx | NFT | 2020-09-25 | 21 |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | NFT | 2018-12-03 | 67 |
| K173229 | Preview Digital Pregnancy Test | LCX | 2018-03-12 | 159 |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | KHE | 2017-05-14 | 265 |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) | DIO | 2016-06-27 | 59 |
33 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-05-18.
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.
Device clinical trials
An industry sponsor named Guangzhou Wondfo Biotech Co., Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04207554: Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test (Completed, started 2019-12-05)
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 Xinbo Electronic Co., Ltd. (12 510(k)s)
- Guangzhou Red Pine Medical Instrument Co., Ltd. (10 510(k)s)
- Guangzhou Decheng Biotechnology Co., Ltd. (8 510(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 Wondfo Biotech Co., Ltd.?
FDA lists 43 510(k) clearances under the applicant name “Guangzhou Wondfo Biotech Co., Ltd.” (first 2005, latest 2026), across 20 product codes in 4 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 Wondfo Biotech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangzhou Wondfo Biotech Co., Ltd. is 61 days. Since 2017: 109 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangzhou Wondfo Biotech Co., Ltd.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 8); DKZ (Enzyme Immunoassay, Amphetamine, 6); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 4).
Next steps
- See all 43 Guangzhou Wondfo Biotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Guangzhou Wondfo Biotech 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.