Hangzhou AllTest Biotech Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Hangzhou AllTest Biotech Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: AllTest Strep A Rapid Test, AllTest Urinary Tract Infection Test, Shinetell PlusTM Digital Early Pregnancy Test
14
Total
14
Cleared
0
Denied
Hangzhou AllTest Biotech Co., Ltd. has 14 FDA 510(k) cleared medical devices. Based in Hangzhou, CN.
Latest FDA clearance: Apr 2026. Active since 2019. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Hangzhou AllTest Biotech Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by LSI International, Inc. and Ivdd Regulatory Consultant.
FDA 510(k) Regulatory Record - Hangzhou AllTest Biotech Co., Ltd.
14 devices
Cleared
Apr 30, 2026
AllTest Strep A Rapid Test
Microbiology
87d
Cleared
Oct 30, 2025
AllTest Urinary Tract Infection Test
Chemistry
73d
Cleared
Jul 15, 2025
Shinetell PlusTM Digital Early Pregnancy Test
Chemistry
102d
Cleared
Apr 04, 2025
AllTest Viral Transport Medium
Microbiology
218d
Cleared
Apr 04, 2025
AllTest Multi-Drug Rapid Urine Test Cup
Toxicology
24d
Cleared
Feb 27, 2025
AllTest Multi-Drug Rapid Test Cup
Toxicology
59d
Cleared
Sep 27, 2024
AllTest Multi-Drug Urine Test Panel
Toxicology
32d
Cleared
Aug 13, 2024
Shinetell Digital Pregnancy Test
Chemistry
39d
Cleared
Jun 17, 2024
AllTest Multi-Drug Urine Test Cup
Toxicology
28d
Cleared
Dec 13, 2023
AllTest Multi-Drug Rapid Test Cup
Toxicology
82d
Cleared
Oct 26, 2023
AllTest Fentanyl Urine Test Cassette
Toxicology
16d
Cleared
Jul 31, 2023
AllTest Fentanyl Rapid Test (Urine)
Toxicology
49d