Hangzhou Clongene Biotech Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Hangzhou Clongene Biotech Co., Ltd.” (first 2016, latest 2026), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 51 days. Since 2017 the median was 29 days, against 61 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 |
|---|---|---|
| 2016 | 2 | 100 |
| 2017 | 0 | — |
| 2018 | 2 | 25 |
| 2019 | 2 | 28 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 52 |
| 2025 | 1 | 51 |
| 2026 | 1 | 122 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hangzhou Clongene Biotech Co., Ltd. took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 61 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NGL | Test, Opiates, Over The Counter | 3 | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
| NFT | Test, Amphetamine, Over The Counter | 1 | 1 |
| PTH | Test, Barbiturate, Over The Counter | 1 | 1 |
Review panels
Most recent Hangzhou Clongene Biotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid Test | GQG | 2026-01-30 | 122 |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | NFT | 2025-08-27 | 51 |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | NGL | 2024-11-08 | 52 |
| K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream | LCX | 2019-12-11 | 29 |
| K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | NGL | 2019-03-21 | 28 |
| K181790 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | NGL | 2018-07-26 | 21 |
| K180255 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | PTH | 2018-02-28 | 29 |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests | DKZ | 2016-08-30 | 119 |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test | LDJ | 2016-03-18 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Hangzhou Clongene Biotech 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.
- Hangzhou AGS MedTech Co., Ltd. (19 510(k)s)
- Hangzhou AllTest Biotech Co., Ltd. (14 510(k)s)
- Hangzhou Hua'An Medical & Health Instruments Co., (10 510(k)s)
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (6 510(k)s)
- Hangzhou SHINING3D Dental Technology Co., Ltd. (5 510(k)s)
- Hangzhou Bever Medical Devices Co., Ltd. (4 510(k)s)
- Hangzhou Jimushi Meditech Co., Ltd. (3 510(k)s)
- Hangzhou Kangji Medical Instrument Co., Ltd. (3 510(k)s)
- Hangzhou Laihe Biotech Co., Ltd. (3 510(k)s)
- Hangzhou Tappa Medical Technology Co., Ltd. (3 510(k)s)
- Hangzhou Primecare Medical Co., Ltd. (2 510(k)s)
- Hangzhou Runheng Medical Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hangzhou Clongene Biotech Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Hangzhou Clongene Biotech Co., Ltd.” (first 2016, latest 2026), across 7 product codes in 3 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 Hangzhou Clongene Biotech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hangzhou Clongene Biotech Co., Ltd. is 51 days. Since 2017: 29 days, versus 61 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hangzhou Clongene Biotech Co., Ltd.?
The most frequent FDA product codes under this applicant name are NGL (Test, Opiates, Over The Counter, 3); DKZ (Enzyme Immunoassay, Amphetamine, 1); GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, 1).
Next steps
- See all 9 Hangzhou Clongene Biotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NGL, Hangzhou Clongene 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, 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.