Guangzhou Wondfo Biotech Co., Ltd.: FDA clearances and approvals
Guangzhou Wondfo Biotech Co., Ltd. has 43 FDA 510(k) clearances (first 2005, latest 2026), across 20 product codes in 4 review panels. Median 510(k) review time: 61 days. Since 2017 its median was 109 days, against 122 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named Guangzhou Wondfo Biotech Co., Ltd. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
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, Guangzhou Wondfo Biotech Co., Ltd.'s cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Guangzhou Wondfo Biotech Co., Ltd. is the industry 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)
Frequently asked questions
How many FDA 510(k) clearances does Guangzhou Wondfo Biotech Co., Ltd. have?
Guangzhou Wondfo Biotech Co., Ltd. has 43 FDA 510(k) clearances (first 2005, latest 2026), across 20 product codes in 4 review panels.
How long does FDA take to clear Guangzhou Wondfo Biotech Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Guangzhou Wondfo Biotech Co., Ltd.'s cleared 510(k)s is 61 days. Since 2017: 109 days, versus 122 days for all cleared 510(k)s in the same product codes.
What devices does Guangzhou Wondfo Biotech Co., Ltd. make?
Its most frequent FDA product codes are DJG (Enzyme Immunoassay, Opiates, 8); DKZ (Enzyme Immunoassay, Amphetamine, 6); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 4).
Has Guangzhou Wondfo Biotech Co., Ltd. had device recalls?
openFDA lists 3 product recalls in 1 recall event by a recalling firm whose name matches Guangzhou Wondfo Biotech Co., Ltd; the most recent began 2018-05-18. Recall firm names are matched by name, so related entities filing under other names are not included.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.