Medical Device Manufacturer · CN , Hangzhou

Assure Tech. Co., Ltd.

3 submissions · 3 cleared · Since 2015
3
Total
3
Cleared
0
Denied

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

Assure Tech. Co., Ltd. has submitted 3 FDA 510(k) premarket notifications since 2015, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Barbiturate, Enzyme Immunoassay, Methadone, Visual, Pregnancy Hcg, Prescription Use . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
K152768 · JHI Visual, Pregnancy Hcg,... · Chemistry
Feb 2016 153d
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
K152025 · DJR Enzyme Immunoassay,... · Chemistry
Oct 2015 75d
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
K151211 · DIS Enzyme Immunoassay,... · Toxicology
Jun 2015 29d
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All3 Chemistry 2 Toxicology 1