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

    ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN

    K Number: K010455 · Decision Jun 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    129

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    Basic Information

    Device Name
    ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
    K Number
    K010455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostica-Stago
    Date Received
    January 29, 2001
    Decision Date
    June 7, 2001
    Product Code
    KFF
    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
    KFF Assay, Heparin

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