# Hangzhou AllTest Biotech Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 14 (2019–2026): 14 510(k) clearances
- Product codes: NFT (4), LCX (2), DKZ (2), JSM (1), DJG (1), JHI (1), NGL (1), JMT (1), GTY (1)
- 510(k) review time since 2016: median 54 days, against 111 for FDA's reviews in the same codes and years (6 of 10 faster)
- Predicates its devices cite: 14 (6 its own); citations of its devices by later devices: 21 (6 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
- Guangzhou Wondfo Biotech Co., Ltd.: 2 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Shenzhen Superbio Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-superbio-technology)
- Alfa Scientific Designs, Inc.: 1 (https://510kreport.com/company/alfa-scientific-designs)
- Polymed Therapeutics, Inc.: 1 (https://510kreport.com/company/polymed-therapeutics)
- Guangzhou Decheng Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-decheng-biotechnology)
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)

## Firms that cite its devices most
- Hangzhou Clongene Biotech Co., Ltd.: 2 (https://510kreport.com/company/hangzhou-clongene-biotech)
- Innovita (Tangshan) Biological Technology Co., Ltd.: 1 (https://510kreport.com/company/innovita-tangshan-biological-technology)
- Guangzhou Decheng Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-decheng-biotechnology)
- Advin Biotech, Inc.: 1 (https://510kreport.com/company/advin-biotech)
- Allsource Screening Solutions: 1 (https://510kreport.com/company/allsource-screening-solutions)
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)
- Instanosis, Inc.: 1 (https://510kreport.com/company/instanosis)
- Qingdao Hightop Biotech Co., Ltd.: 1 (https://510kreport.com/company/qingdao-hightop-biotech)

## Its most-cited devices
- K233417: AllTest Fentanyl Urine Test Cassette (2023), cited by 8
- K244043: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (2025), cited by 3
- K231698: AllTest Fentanyl Rapid Test (Urine) (2023), cited by 2
- K233019: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx (2023), cited by 2
- K203272: Alltest Pregnancy Rapid Combo Test Cassette (2022), cited by 2
- K241428: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (2024), cited by 2

## Recent decisions
- K260342: AllTest Strep A Rapid Test (Apr 30, 2026)
- K252607: AllTest Urinary Tract Infection Test (Oct 30, 2025)
- K251053: Shinetell PlusTM Digital Early Pregnancy Test (Jul 15, 2025)
- K242576: AllTest Viral Transport Medium (Apr 4, 2025)
- K250727: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (Apr 4, 2025)
- K244043: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (Feb 27, 2025)
- K242540: AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (Sep 27, 2024)
- K241978: Shinetell Digital Pregnancy Test (Aug 13, 2024)

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