BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    MyCare Psychiatry Clozapine Assay Kit

    K Number: DEN190028 · Decision Apr 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    328

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    Basic Information

    Device Name
    MyCare Psychiatry Clozapine Assay Kit
    K Number
    DEN190028
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.3245
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Saladax Biomedical, Inc.
    Date Received
    May 24, 2019
    Decision Date
    April 16, 2020
    Product Code
    QKT
    Advisory Committee
    Clinical Chemistry
    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
    QKT Clozapine Test System