Hangzhou AllTest Biotech Co., Ltd.: FDA clearances and approvals
Hangzhou AllTest Biotech Co., Ltd. has 14 FDA 510(k) clearances (first 2019, latest 2026), across 9 product codes in 3 review panels. Median 510(k) review time: 66 days. Since 2017 its median was 66 days, against 112 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 180 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 451 |
| 2023 | 3 | 49 |
| 2024 | 3 | 32 |
| 2025 | 5 | 73 |
| 2026 | 1 | 87 |
Review time against the same product codes
Since 2017, Hangzhou AllTest Biotech Co., Ltd.'s cleared 510(k)s took a median 66 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 | 4 | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| NGL | Test, Opiates, Over The Counter | 1 | 1 |
Review panels
Most recent Hangzhou AllTest Biotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260342 | AllTest Strep A Rapid Test | GTY | 2026-04-30 | 87 |
| K252607 | AllTest Urinary Tract Infection Test | JMT | 2025-10-30 | 73 |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | LCX | 2025-07-15 | 102 |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | NFT | 2025-04-04 | 24 |
| K242576 | AllTest Viral Transport Medium | JSM | 2025-04-04 | 218 |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | NFT | 2025-02-27 | 59 |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | NFT | 2024-09-27 | 32 |
| K241978 | Shinetell Digital Pregnancy Test | LCX | 2024-08-13 | 39 |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | NFT | 2024-06-17 | 28 |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | DKZ | 2023-12-13 | 82 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hangzhou AllTest Biotech Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hangzhou AllTest Biotech Co., Ltd. have?
Hangzhou AllTest Biotech Co., Ltd. has 14 FDA 510(k) clearances (first 2019, latest 2026), across 9 product codes in 3 review panels.
How long does FDA take to clear Hangzhou AllTest Biotech Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Hangzhou AllTest Biotech Co., Ltd.'s cleared 510(k)s is 66 days. Since 2017: 66 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Hangzhou AllTest Biotech Co., Ltd. make?
Its most frequent FDA product codes are NFT (Test, Amphetamine, Over The Counter, 4); DKZ (Enzyme Immunoassay, Amphetamine, 2); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2).
Has Hangzhou AllTest Biotech Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hangzhou AllTest Biotech Co., Ltd. Related entities may recall under other names.
Next steps
- See all 14 Hangzhou AllTest Biotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NFT, Hangzhou AllTest Biotech Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.