Company · CN
Assure Tech. (Hangzhou) Co, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2024. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 5, 2024 | K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream Assure Tech. (Hangzhou) Co, Ltd., CN | LCX |
| Aug 12, 2021 | K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests Assure Tech. (Hangzhou) Co, Ltd., CN | DJG |
| Aug 20, 2018 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech. (Hangzhou) Co, Ltd., CN | NFT |
| Apr 5, 2018 | K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech. (Hangzhou) Co, Ltd., CN | NFT |
| May 2, 2017 | K170049 | AssureTech Panel Dip Test, AssureTech Quick Cup Test Assure Tech. (Hangzhou) Co, Ltd., CN | NFT |
| Jul 6, 2016 | K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (St Assure Tech. (Hangzhou) Co, Ltd., CN | DJC |
| Mar 31, 2016 | K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card Assure Tech. (Hangzhou) Co, Ltd., CN | DKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||