Medical Device Manufacturer · CN , Hangzhou

Assure Tech. (Hangzhou) Co, Ltd.

7 submissions · 7 cleared · Since 2016
7
Total
7
Cleared
0
Denied

Assure Tech. (Hangzhou) Co, Ltd. — FDA 510(k) Submissions

Assure Tech. (Hangzhou) Co, Ltd. has submitted 7 FDA 510(k) premarket notifications since 2016, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Amphetamine, Over The Counter, Enzyme Immunoassay, Opiates, Kit, Test, Pregnancy, Hcg, Over The Counter, Enzyme Immunoassay, Amphetamine, Thin Layer Chromatography, Methamphetamine . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
FaStep? Pregnancy Rapid Test Strip; FaStep? Pregnancy Rapid Test Midstream
K233174 · LCX Kit, Test, Pregnancy,... · Chemistry
Feb 2024 130d
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
K201630 · DJG Enzyme Immunoassay, Opiates · Toxicology
Aug 2021 422d
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K181768 · NFT Test, Amphetamine, Over... · Toxicology
Aug 2018 48d
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K180349 · NFT Test, Amphetamine, Over... · Toxicology
Apr 2018 56d
AssureTech Panel Dip Test, AssureTech Quick Cup Test
K170049 · NFT Test, Amphetamine, Over... · Toxicology
May 2017 117d
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)
K161044 · DJC Thin Layer... · Toxicology
Jul 2016 84d
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)
K153465 · DKZ Enzyme Immunoassay,... · Toxicology
Mar 2016 121d
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