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

    picoAMH ELISA

    K Number: DEN180004 · Decision Oct 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    275

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    Basic Information

    Device Name
    picoAMH ELISA
    K Number
    DEN180004
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    862.1093
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Ansh Labs, LLC
    Date Received
    January 22, 2018
    Decision Date
    October 24, 2018
    Product Code
    QDH
    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
    QDH Menopause Test System