FDA 510(k) Applications Submitted by Shisheng Ling

FDA 510(k) Number Submission Date Device Name Applicant
K170049 01/05/2017 AssureTech Panel Dip Test, AssureTech Quick Cup Test ASSURE TECH (HANGZHOU) CO., LTD.
K180349 02/08/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd.
K161044 04/13/2016 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) ASSURE TECH (HANGZHOU) CO., LTD.
K201630 06/16/2020 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests Assure Tech (Hangzhou) Co., Ltd.
K181768 07/03/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd.
K153465 12/01/2015 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) Assure Tech (Hangzhou) Co., Ltd.


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