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

    BIOCHRON FERTILITY INDICATOR

    K Number: K852801 · Decision Sep 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    BIOCHRON FERTILITY INDICATOR
    K Number
    K852801
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Fertil-A-Chron, Inc.
    Date Received
    July 1, 1985
    Decision Date
    September 19, 1985
    Product Code
    LHD
    Advisory Committee
    Unknown
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LHD Device, Fertility Diagnostic, Proceptive

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