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

    SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

    K Number: K240654 · Decision Apr 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    22
    Applicant Total
    9
    Review Days
    34

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    Basic Information

    Device Name
    SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
    K Number
    K240654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Safecare Biotech (Hangzhou) Co., Ltd.
    Date Received
    March 7, 2024
    Decision Date
    April 10, 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 Safecare Biotech (Hangzhou) Co., Ltd.

    K Number Device Name
    K242767 Safecare Urinary Tract Infection Test
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    K200133 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
    K201120 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
    K191924 SAFECARE® THC Urine Strip Test
    K182654 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
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    K153646 SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana