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. |
| K250117 |
01/16/2025 |
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette |
Assure Tech LLC |
| 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. |
| K233174 |
09/28/2023 |
FaStepÖ Pregnancy Rapid Test Strip; FaStepÖ Pregnancy Rapid Test Midstream |
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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