BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    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)

    K Number: K182738 · Decision Mar 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    14
    Review Days
    180

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    Basic Information

    Device Name
    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)
    K Number
    K182738
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou AllTest Biotech Co., Ltd.
    Date Received
    September 28, 2018
    Decision Date
    March 27, 2019
    Product Code
    DKZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Hangzhou AllTest Biotech Co., Ltd.

    K Number Device Name
    K260342 AllTest Strep A Rapid Test
    K252607 AllTest Urinary Tract Infection Test
    K251053 Shinetell PlusTM Digital Early Pregnancy Test
    K242576 AllTest Viral Transport Medium
    K250727 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
    K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
    K242540 AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
    K241978 Shinetell Digital Pregnancy Test
    K241428 AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
    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 Rx
    Search all 14 clearances from Hangzhou AllTest Biotech Co., Ltd. →