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

    REFACTO LABORATORY STANDARD

    K Number: K002350 · Decision Oct 5, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    1
    Review Days
    64

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    Basic Information

    Device Name
    REFACTO LABORATORY STANDARD
    K Number
    K002350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Genetics Institute
    Date Received
    August 2, 2000
    Decision Date
    October 5, 2000
    Product Code
    GGP
    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
    GGP Test, Qualitative And Quantitative Factor Deficiency

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