# Assure Tech. (Hangzhou) Co, Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 7 (2016–2024): 7 510(k) clearances
- Product codes: NFT (3), LCX (1), DJC (1), DKZ (1), DJG (1)
- 510(k) review time since 2016: median 121 days, against 132 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 5 (1 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
- Chemtron Biotech, Inc.: 3 (https://510kreport.com/company/chemtron-biotech)
- Advin Biotech, Inc.: 2 (https://510kreport.com/company/advin-biotech)
- Polymed Therapeutics, Inc.: 1 (https://510kreport.com/company/polymed-therapeutics)
- Co-Innovation Biotech Co., Ltd.: 1 (https://510kreport.com/company/co-innovation-biotech)

## Firms that cite its devices most
- Shenzhen Bioeasy Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-bioeasy-biotechnology)
- Guangzhou Decheng Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-decheng-biotechnology)
- Hangzhou Clongene Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-clongene-biotech)
- Assure Tech., LLC: 1 (https://510kreport.com/company/assure-tech)

## Its most-cited devices
- K181768: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (2018), cited by 2
- K201630: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (2021), cited by 2
- K180349: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (2018), cited by 1

## Recent decisions
- K233174: FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream (Feb 5, 2024)
- K201630: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (Aug 12, 2021)
- K181768: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (Aug 20, 2018)
- K180349: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (Apr 5, 2018)
- K170049: AssureTech Panel Dip Test, AssureTech Quick Cup Test (May 2, 2017)
- K161044: AssureTech Methamphetamine  Tests (Strip, Panel Dip, Quick Cup, Turn-Key  Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana  Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (Jul 6, 2016)
- K153465: AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) (Mar 31, 2016)

Source page: https://510kreport.com/company/assure-tech-hangzhou