Medical Device Manufacturer · CN , Hangzhou

Hangzhou Clongene Biotech Co., Ltd. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2016

Recent clearances: Clungene RSV Antigen Rapid Test, CLUNGENE Multi-Drug Test Easy Cup, CLUNGENE Fentanyl Home Test Cassette

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hangzhou Clongene Biotech Co., Ltd. Chemistry ✕

1 devices

1-1 of 1

Cleared Dec 11, 2019

CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test...

Chemistry · 29d