Medical Device Manufacturer · CN , Hangzhou

Safecare Biotech (Hangzhou) Co., Ltd.

9 submissions · 9 cleared · Since 2016
9
Total
9
Cleared
0
Denied

Safecare Biotech (Hangzhou) Co., Ltd. — FDA 510(k) Submissions

Safecare Biotech (Hangzhou) Co., Ltd. has submitted 9 FDA 510(k) premarket notifications since 2016, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Amphetamine, Over The Counter, Kit, Test, Pregnancy, Hcg, Over The Counter, Test, Opiates, Over The Counter, Diazo (colorimetric), Nitrite (urinary, Non-quant), Enzyme Immunoassay, Cocaine And Cocaine Metabolites . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
Safecare Urinary Tract Infection Test
K242767 · JMT Diazo (colorimetric),... · Chemistry
Jan 2025 119d
SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
K240654 · NGL Test, Opiates, Over The... · Toxicology
Apr 2024 34d
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
K202453 · NFT Test, Amphetamine, Over... · Toxicology
Mar 2021 209d
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
K200133 · LCX Kit, Test, Pregnancy,... · Chemistry
Aug 2020 205d
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K201120 · NFT Test, Amphetamine, Over... · Toxicology
May 2020 30d
SAFECARE? THC Urine Strip Test
K191924 · NFW Test, Cannabinoid, Over... · Toxicology
Aug 2019 29d
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K182654 · NGG Test, Methamphetamine,... · Toxicology
Nov 2018 55d
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
K181968 · NFT Test, Amphetamine, Over... · Toxicology
Aug 2018 27d
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
K153646 · DIO Enzyme Immunoassay,... · Toxicology
Mar 2016 88d
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