Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Hangzhou Clongene Biotech with 9 510(k) clearances. The most recent is a 510(k) clearance dated Jan 30, 2026: Clungene RSV Antigen Rapid Test.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 30, 2026 | Clungene RSV Antigen Rapid TestK253318 · GQG | 510(k) clearances |
| Aug 27, 2025 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupK252118 · NFT | 510(k) clearances |
| Nov 8, 2024 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteK242802 · NGL | 510(k) clearances |
| Dec 11, 2019 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test MidstreamK193132 · LCX | 510(k) clearances |
| Mar 21, 2019 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupK190412 · NGL | 510(k) clearances |
| Jul 26, 2018 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupK181790 · NGL | 510(k) clearances |
| Feb 28, 2018 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupK180255 · PTH | 510(k) clearances |
| Aug 30, 2016 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsK161251 · DKZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
