Hangzhou Clongene Biotech Co., Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Clungene RSV Antigen Rapid Test510(k)Jan 30, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 30, 2026
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup510(k)Aug 27, 2025Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Aug 27, 2025
CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette510(k)Nov 8, 2024Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Nov 8, 2024