Hangzhou Clongene Biotech Co., Ltd. - FDA 510(k) Cleared Devices
9
Total
9
Cleared
0
Denied
Hangzhou Clongene Biotech Co., Ltd. has 9 FDA 510(k) cleared medical devices. Based in Hangzhou, CN.
Latest FDA clearance: Jan 2026. Active since 2016. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Hangzhou Clongene Biotech Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by LSI International, Inc. as regulatory consultant.
9 devices
Cleared
Jan 30, 2026
Clungene RSV Antigen Rapid Test
Microbiology
122d
Cleared
Aug 27, 2025
CLUNGENE Multi-Drug Test Easy Cup
Toxicology
51d
Cleared
Nov 08, 2024
CLUNGENE Fentanyl Home Test Cassette
Toxicology
52d
Cleared
Dec 11, 2019
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test...
Chemistry
29d
Cleared
Mar 21, 2019
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Toxicology
28d
Cleared
Jul 26, 2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Toxicology
21d
Cleared
Feb 28, 2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Toxicology
29d
Cleared
Aug 30, 2016
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
Toxicology
119d
Cleared
Mar 18, 2016
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
Toxicology
81d