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Assure Tech. (Hangzhou) Co, Ltd.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories5
Latest Approval2024-02-05
TypeNumberDevice NameCodeDate
510(k) K233174 FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream LCX 2024-02-05 View
510(k) K201630 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests DJG 2021-08-12 View
510(k) K181768 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests NFT 2018-08-20 View
510(k) K180349 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests NFT 2018-04-05 View
510(k) K170049 AssureTech Panel Dip Test, AssureTech Quick Cup Test NFT 2017-05-02 View
510(k) K161044 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) DJC 2016-07-06 View
510(k) K153465 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) DKZ 2016-03-31 View