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

    SAFECARE® THC Urine Strip Test

    K Number: K191924 · Decision Aug 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    SAFECARE® THC Urine Strip Test
    K Number
    K191924
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Safecare Biotech (Hangzhou) Co., Ltd.
    Date Received
    July 18, 2019
    Decision Date
    August 16, 2019
    Product Code
    NFW
    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
    NFW Test, Cannabinoid, Over The Counter

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    Other Clearances by Safecare Biotech (Hangzhou) Co., Ltd.

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    K202453 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
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    K182654 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
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