Assure Tech. (Hangzhou) Co, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Assure Tech. (Hangzhou) Co, Ltd.” (first 2016, latest 2024), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 117 days. Since 2017 the median was 117 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 102 |
| 2017 | 1 | 117 |
| 2018 | 2 | 52 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 422 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 130 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Assure Tech. (Hangzhou) Co, Ltd. took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | 3 | 3 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
Most recent Assure Tech. (Hangzhou) Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | LCX | 2024-02-05 | 130 |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | DJG | 2021-08-12 | 422 |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | NFT | 2018-08-20 | 48 |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | NFT | 2018-04-05 | 56 |
| K170049 | AssureTech Panel Dip Test, AssureTech Quick Cup Test | NFT | 2017-05-02 | 117 |
| 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 | 84 |
| 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 | 121 |
Recalls
openFDA lists no recalls under a recalling firm named Assure Tech. (Hangzhou) Co, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Assure Tech., LLC (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Assure Tech. (Hangzhou) Co, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Assure Tech. (Hangzhou) Co, Ltd.” (first 2016, latest 2024), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Assure Tech. (Hangzhou) Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Assure Tech. (Hangzhou) Co, Ltd. is 117 days. Since 2017: 117 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Assure Tech. (Hangzhou) Co, Ltd.?
The most frequent FDA product codes under this applicant name are NFT (Test, Amphetamine, Over The Counter, 3); DJC (Thin Layer Chromatography, Methamphetamine, 1); DJG (Enzyme Immunoassay, Opiates, 1).
Next steps
- See all 7 Assure Tech. (Hangzhou) Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NFT, Assure Tech. (Hangzhou) Co, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.