Medical Device Manufacturer · CN , Hangzhou

Hangzhou Clongene Biotech Co., Ltd.

9 submissions · 9 cleared · Since 2016
9
Total
9
Cleared
0
Denied

Hangzhou Clongene Biotech Co., Ltd. — FDA 510(k) Submissions

Hangzhou Clongene Biotech Co., Ltd. has submitted 9 FDA 510(k) premarket notifications since 2016, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Opiates, Over The Counter, Test, Amphetamine, Over The Counter, Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus, Enzyme Immunoassay, Cannabinoids, Enzyme Immunoassay, Amphetamine . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
Clungene RSV Antigen Rapid Test
K253318 · GQG Antigen, Cf (including Cf... · Microbiology
Jan 2026 122d
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
K252118 · NFT Test, Amphetamine, Over... · Toxicology
Aug 2025 51d
CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
K242802 · NGL Test, Opiates, Over The... · Toxicology
Nov 2024 52d
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
K193132 · LCX Kit, Test, Pregnancy,... · Chemistry
Dec 2019 29d
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K190412 · NGL Test, Opiates, Over The... · Toxicology
Mar 2019 28d
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K181790 · NGL Test, Opiates, Over The... · Toxicology
Jul 2018 21d
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K180255 · PTH Test, Barbiturate, Over... · Toxicology
Feb 2018 29d
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
K161251 · DKZ Enzyme Immunoassay,... · Toxicology
Aug 2016 119d
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
K153741 · LDJ Enzyme Immunoassay,... · Toxicology
Mar 2016 81d
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