BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Proov Test

    K Number: K191462 · Decision Feb 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    269

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    Basic Information

    Device Name
    Proov Test
    K Number
    K191462
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1620
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mfb Fertility, Inc.
    Date Received
    June 3, 2019
    Decision Date
    February 27, 2020
    Product Code
    QKE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter