Safecare Biotech (Hangzhou) Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Safecare Biotech (Hangzhou) Co., Ltd. - FDA 510(k) Cleared Devices
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
Safecare Biotech (Hangzhou) Co., Ltd. has 9 FDA 510(k) cleared medical devices. Based in Hangzhou, CN.
Latest FDA clearance: Jan 2025. Active since 2016. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Safecare Biotech (Hangzhou) Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Lsi International and LSI International, Inc..
FDA 510(k) Regulatory Record - Safecare Biotech (Hangzhou) Co., Ltd.
9 devices
Cleared
Jan 10, 2025
Safecare Urinary Tract Infection Test
Chemistry
119d
Cleared
Apr 10, 2024
SAFECARE Fentanyl Urine Test Cassette
Toxicology
34d
Cleared
Mar 24, 2021
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
Toxicology
209d
Cleared
Aug 13, 2020
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
Chemistry
205d
Cleared
May 27, 2020
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
Toxicology
30d
Cleared
Aug 16, 2019
SAFECARE® THC Urine Strip Test
Toxicology
29d
Cleared
Nov 19, 2018
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
Toxicology
55d
Cleared
Aug 20, 2018
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
Toxicology
27d
Cleared
Mar 18, 2016
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine...
Toxicology
88d