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

    FETALTROL

    K Number: K002511 · Decision Sep 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    191
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    FETALTROL
    K Number
    K002511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trillium Diagnostics, LLC
    Date Received
    August 15, 2000
    Decision Date
    September 11, 2000
    Product Code
    JPK
    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
    JPK Mixture, Hematology Quality Control

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