Assure Tech. (Hangzhou) Co, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | February 5, 2024 |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | August 12, 2021 |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | August 20, 2018 |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | April 5, 2018 |
| K170049 | AssureTech Panel Dip Test, AssureTech Quick Cup Test | May 2, 2017 |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phe | July 6, 2016 |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Te | March 31, 2016 |