Company ยท CN
Hangzhou Clongene Biotech Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NGL | Test, Opiates, Over The Counter | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
| NFT | Test, Amphetamine, Over The Counter | 1 |
| PTH | Test, Barbiturate, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2026 | K253318 | Clungene RSV Antigen Rapid Test Hangzhou Clongene Biotech Co., Ltd., CN | GQG |
| Aug 27, 2025 | K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup Hangzhou Clongene Biotech Co., Ltd., CN | NFT |
| Nov 8, 2024 | K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette Hangzhou Clongene Biotech Co., Ltd., CN | NGL |
| Dec 11, 2019 | K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test M Hangzhou Clongene Biotech Co., Ltd., CN | LCX |
| Mar 21, 2019 | K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co., Ltd., CN | NGL |
| Jul 26, 2018 | K181790 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co., Ltd., CN | NGL |
| Feb 28, 2018 | K180255 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co., Ltd., CN | PTH |
| Aug 30, 2016 | K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests Hangzhou Clongene Biotech Co., Ltd., CN | DKZ |
| Mar 18, 2016 | K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test Hangzhou Clongene Biotech Co., Ltd., CN | LDJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||