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Hangzhou AllTest Biotech Co., Ltd. FDA Approvals
0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| AllTest Strep A Rapid Test510(k)Apr 30, 2026Microbiology |
| AllTest Urinary Tract Infection Test510(k)Oct 30, 2025Clinical Chemistry |
| Shinetell PlusTM Digital Early Pregnancy Test510(k)Jul 15, 2025Clinical Chemistry |
| AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup510(k)Apr 4, 2025Clinical Toxicology |
| AllTest Viral Transport Medium510(k)Apr 4, 2025Microbiology |
| AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup510(k)Feb 27, 2025Clinical Toxicology |
| AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel510(k)Sep 27, 2024Clinical Toxicology |
| Shinetell Digital Pregnancy Test510(k)Aug 13, 2024Clinical Chemistry |
| AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup510(k)Jun 17, 2024Clinical Toxicology |
| 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 Rx510(k)Dec 13, 2023Clinical Toxicology |
| AllTest Fentanyl Urine Test Cassette510(k)Oct 26, 2023Clinical Toxicology |
| AllTest Fentanyl Rapid Test (Urine)510(k)Jul 31, 2023Clinical Toxicology |
| Alltest Pregnancy Rapid Combo Test Cassette510(k)Jan 31, 2022Clinical Chemistry |