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Hangzhou Clongene Biotech Co., Ltd.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories7
Latest FDA decision2026-01-30
TypeNumberDevice NameCodeDateActions
510(k) K253318 Clungene RSV Antigen Rapid TestGQG2026-01-30 View
510(k) K252118 CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupNFT2025-08-27 View
510(k) K242802 CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteNGL2024-11-08 View
510(k) K193132 CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test MidstreamLCX2019-12-11 View
510(k) K190412 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupNGL2019-03-21 View
510(k) K181790 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupNGL2018-07-26 View
510(k) K180255 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupPTH2018-02-28 View
510(k) K161251 CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsDKZ2016-08-30 View
510(k) K153741 CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ2016-03-18 View
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