Medical Device Manufacturer · CN , Hangzhou

Safecare Biotech (Hangzhou) Co., Ltd. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2016

Recent clearances: Safecare Urinary Tract Infection Test, SAFECARE Fentanyl Urine Test Cassette, SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Safecare Biotech (Hangzhou) Co., Ltd. Chemistry ✕

2 devices

1-2 of 2

Cleared Jan 10, 2025

Safecare Urinary Tract Infection Test

Chemistry · 119d

Cleared Aug 13, 2020

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream

Chemistry · 205d