Hangzhou Clongene Biotech Co., Ltd.
Hangzhou Clongene Biotech Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2026.
Top product codes for Hangzhou Clongene Biotech Co., Ltd.
Recent clearances by Hangzhou Clongene Biotech Co., Ltd.
- K253318 — Clungene RSV Antigen Rapid Test
- K252118 — CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
- K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
- K193132 — CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
- K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K181790 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
- K161251 — CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
- K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.