Medical Device Manufacturer · CN , Hangzhou

Hangzhou AllTest Biotech Co., Ltd.

13 submissions · 13 cleared · Since 2019
13
Total
13
Cleared
0
Denied

Hangzhou AllTest Biotech Co., Ltd. — FDA 510(k) Submissions

Hangzhou AllTest Biotech Co., Ltd. has submitted 13 FDA 510(k) premarket notifications since 2019, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Amphetamine, Over The Counter, Enzyme Immunoassay, Amphetamine, Kit, Test, Pregnancy, Hcg, Over The Counter, Diazo (colorimetric), Nitrite (urinary, Non-quant), Visual, Pregnancy Hcg, Prescription Use . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
AllTest Urinary Tract Infection Test
K252607 · JMT Diazo (colorimetric),... · Chemistry
Oct 2025 73d
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · LCX Kit, Test, Pregnancy,... · Chemistry
Jul 2025 102d
AllTest Viral Transport Medium
K242576 · JSM Culture Media,... · Microbiology
Apr 2025 218d
AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
K250727 · NFT Test, Amphetamine, Over... · Toxicology
Apr 2025 24d
AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
K244043 · NFT Test, Amphetamine, Over... · Toxicology
Feb 2025 59d
AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
K242540 · NFT Test, Amphetamine, Over... · Toxicology
Sep 2024 32d
Shinetell Digital Pregnancy Test
K241978 · LCX Kit, Test, Pregnancy,... · Chemistry
Aug 2024 39d
AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
K241428 · NFT Test, Amphetamine, Over... · Toxicology
Jun 2024 28d
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 Rx
K233019 · DKZ Enzyme Immunoassay,... · Toxicology
Dec 2023 82d
AllTest Fentanyl Urine Test Cassette
K233417 · NGL Test, Opiates, Over The... · Toxicology
Oct 2023 16d
AllTest Fentanyl Rapid Test (Urine)
K231698 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2023 49d
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jan 2022 451d
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)
K182738 · DKZ Enzyme Immunoassay,... · Toxicology
Mar 2019 180d
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