Hangzhou AllTest Biotech Co., Ltd.
Medical device manufacturer in Hangzhou, CN.
14510(k) clearances
0PMA approvals
0recalls
Device types
- NFT Test, Amphetamine, Over The Counter 4
- DKZ Enzyme Immunoassay, Amphetamine 2
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 2
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- DJG Enzyme Immunoassay, Opiates 1
- NGL Test, Opiates, Over The Counter 1
- JSM Culture Media, Non-Propagating Transport 1
- JMT Diazo (Colorimetric), Nitrite (Urinary… 1
- GTY Antigens, All Groups, Streptococcus Spp. 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260342 | AllTest Strep A Rapid TestGTY · Traditional | 04/30/2026SE |
| K252607 | AllTest Urinary Tract Infection TestJMT · Traditional | 10/30/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | 07/15/2025SE |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional | 04/04/2025SE |
| K242576 | AllTest Viral Transport MediumJSM · Traditional | 04/04/2025SE |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT · Traditional | 02/27/2025SE |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFT · Traditional | 09/27/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | 08/13/2024SE |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFT · Traditional | 06/17/2024SE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…DKZ · Traditional | 12/13/2023SE |
| K233417 | AllTest Fentanyl Urine Test CassetteNGL · Traditional | 10/26/2023SE |
| K231698 | AllTest Fentanyl Rapid Test (Urine)DJG · Traditional | 07/31/2023SE |
| K203272 | Alltest Pregnancy Rapid Combo Test CassetteJHI · Traditional | 01/31/2022SE |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…DKZ · Traditional | 03/27/2019SE |