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Hangzhou AllTest Biotech Co., Ltd.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories9
Latest FDA decision2026-04-30
TypeNumberDevice NameCodeDateActions
510(k) K260342 AllTest Strep A Rapid TestGTY2026-04-30 View
510(k) K252607 AllTest Urinary Tract Infection TestJMT2025-10-30 View
510(k) K251053 Shinetell PlusTM Digital Early Pregnancy TestLCX2025-07-15 View
510(k) K250727 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT2025-04-04 View
510(k) K242576 AllTest Viral Transport MediumJSM2025-04-04 View
510(k) K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT2025-02-27 View
510(k) K242540 AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFT2024-09-27 View
510(k) K241978 Shinetell Digital Pregnancy TestLCX2024-08-13 View
510(k) K241428 AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFT2024-06-17 View
510(k) 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 RxDKZ2023-12-13 View
510(k) K233417 AllTest Fentanyl Urine Test CassetteNGL2023-10-26 View
510(k) K231698 AllTest Fentanyl Rapid Test (Urine)DJG2023-07-31 View
510(k) K203272 Alltest Pregnancy Rapid Combo Test CassetteJHI2022-01-31 View
510(k) K182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)DKZ2019-03-27 View
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