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

    VALIDATE Heparin Calibration Verification/Linearity Test Kit

    K Number: K163498 · Decision Mar 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    98
    Applicant Total
    7
    Review Days
    93

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    Basic Information

    Device Name
    VALIDATE Heparin Calibration Verification/Linearity Test Kit
    K Number
    K163498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maine Standards Company, LLC
    Date Received
    December 13, 2016
    Decision Date
    March 16, 2017
    Product Code
    GGN
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GGN Plasma, Coagulation Control

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