Company ยท CN
Hangzhou AllTest Biotech Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2026. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| NGL | Test, Opiates, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2026 | K260342 | AllTest Strep A Rapid Test Hangzhou AllTest Biotech Co., Ltd., CN | GTY |
| Oct 30, 2025 | K252607 | AllTest Urinary Tract Infection Test Hangzhou AllTest Biotech Co., Ltd., CN | JMT |
| Jul 15, 2025 | K251053 | Shinetell PlusTM Digital Early Pregnancy Test Hangzhou AllTest Biotech Co., Ltd., CN | LCX |
| Apr 4, 2025 | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup Hangzhou AllTest Biotech Co., Ltd., CN | NFT |
| Apr 4, 2025 | K242576 | AllTest Viral Transport Medium Hangzhou AllTest Biotech Co., Ltd., CN | JSM |
| Feb 27, 2025 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup Hangzhou AllTest Biotech Co., Ltd., CN | NFT |
| Sep 27, 2024 | K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel Hangzhou AllTest Biotech Co., Ltd., CN | NFT |
| Aug 13, 2024 | K241978 | Shinetell Digital Pregnancy Test Hangzhou AllTest Biotech Co., Ltd., CN | LCX |
| Jun 17, 2024 | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup Hangzhou AllTest Biotech Co., Ltd., CN | NFT |
| Dec 13, 2023 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Mu Hangzhou AllTest Biotech Co., Ltd., CN | DKZ |
| Oct 26, 2023 | K233417 | AllTest Fentanyl Urine Test Cassette Hangzhou AllTest Biotech Co., Ltd., CN | NGL |
| Jul 31, 2023 | K231698 | AllTest Fentanyl Rapid Test (Urine) Hangzhou AllTest Biotech Co., Ltd., CN | DJG |
| Jan 31, 2022 | K203272 | Alltest Pregnancy Rapid Combo Test Cassette Hangzhou AllTest Biotech Co., Ltd., CN | JHI |
| Mar 27, 2019 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single Hangzhou AllTest Biotech Co., Ltd., CN | DKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||