# Safecare Biotech (Hangzhou) Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 9 (2016–2025): 9 510(k) clearances
- Product codes: NFT (3), LCX (1), JMT (1), NFW (1), NGL (1), NGG (1), DIO (1)
- 510(k) review time since 2016: median 61 days, against 72 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 4 (3 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.: 2 (https://510kreport.com/company/chemtron-biotech)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)
- First Check Diagnostics, LLC: 1 (https://510kreport.com/company/first-check-diagnostics)

## Firms that cite its devices most
- Anhui Deepblue Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/anhui-deepblue-medical-technology)

## Its most-cited devices
- K200133: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (2020), cited by 1
- K182654: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (2018), cited by 1
- K201120: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (2020), cited by 1
- K153646: SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana (2016), cited by 1

## Recent decisions
- K242767: Safecare Urinary Tract Infection Test (Jan 10, 2025)
- K240654: SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette (Apr 10, 2024)
- K202453: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (Mar 24, 2021)
- K200133: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (Aug 13, 2020)
- K201120: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (May 27, 2020)
- K191924: SAFECARE® THC Urine Strip Test (Aug 16, 2019)
- K182654: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (Nov 19, 2018)
- K181968: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (Aug 20, 2018)

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