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

    CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette

    K Number: K242802 · Decision Nov 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    22
    Applicant Total
    9
    Review Days
    52

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    Basic Information

    Device Name
    CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
    K Number
    K242802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou Clongene Biotech Co., Ltd.
    Date Received
    September 17, 2024
    Decision Date
    November 8, 2024
    Product Code
    NGL
    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
    NGL Test, Opiates, Over The Counter

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    Other Clearances by Hangzhou Clongene Biotech Co., Ltd.

    K Number Device Name
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    K161251 CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
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