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

    PANTRAK E.K.

    K Number: K810669 · Decision Mar 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    41
    Review Days
    19

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    Basic Information

    Device Name
    PANTRAK E.K.
    K Number
    K810669
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Calbiochem-Behring Corp.
    Date Received
    March 12, 1981
    Decision Date
    March 31, 1981
    Product Code
    CIW
    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
    CIW Starch-Dye Bound Polymer, Amylase

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