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

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

    K Number: K182654 · Decision Nov 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    0
    Applicant Total
    9
    Review Days
    55

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    Basic Information

    Device Name
    SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
    K Number
    K182654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Safecare Biotech (Hangzhou) Co., Ltd.
    Date Received
    September 25, 2018
    Decision Date
    November 19, 2018
    Product Code
    NGG
    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
    NGG Test, Methamphetamine, Over The Counter

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

    K Number Device Name
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    K202453 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
    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
    K181968 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
    K153646 SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana