# Hangzhou Clongene Biotech Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 9 (2016–2026): 9 510(k) clearances
- Product codes: NGL (3), LDJ (1), PTH (1), LCX (1), GQG (1), NFT (1), DKZ (1)
- 510(k) review time since 2016: median 52 days, against 45 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 9 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- First Check Diagnostics, LLC: 2 (https://510kreport.com/company/first-check-diagnostics)
- Hangzhou AllTest Biotech Co., Ltd.: 2 (https://510kreport.com/company/hangzhou-alltest-biotech)
- Chemtron Biotech, Inc.: 2 (https://510kreport.com/company/chemtron-biotech)
- Nantong Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/nantong-biotechnology)
- Nano-Ditech Corporation: 1 (https://510kreport.com/company/nano-ditech)
- Assure Tech. (Hangzhou) Co, Ltd.: 1 (https://510kreport.com/company/assure-tech-hangzhou)

## Firms that cite its devices most
- Hangzhou Sejoy Electronics & Instruments Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-sejoy-electronics-instruments)

## Its most-cited devices
- K193132: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream (2019), cited by 1

## Recent decisions
- K253318: Clungene RSV Antigen Rapid Test (Jan 30, 2026)
- K252118: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (Aug 27, 2025)
- K242802: CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (Nov 8, 2024)
- K193132: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream (Dec 11, 2019)
- K190412: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (Mar 21, 2019)
- K181790: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (Jul 26, 2018)
- K180255: CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup (Feb 28, 2018)
- K161251: CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests (Aug 30, 2016)

Source page: https://510kreport.com/company/hangzhou-clongene-biotech