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

    HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED

    K Number: K881477 · Decision Apr 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    11

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    Basic Information

    Device Name
    HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED
    K Number
    K881477
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Stat Path
    Date Received
    April 7, 1988
    Decision Date
    April 18, 1988
    Product Code
    KEL
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KEL Adhesive, Albumin-Based

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