BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MINUTEX D-DIMER LATEX TEST

    K Number: K920668 · Decision Oct 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    27
    Applicant Total
    13
    Review Days
    246

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    Basic Information

    Device Name
    MINUTEX D-DIMER LATEX TEST
    K Number
    K920668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biopool AB
    Date Received
    February 13, 1992
    Decision Date
    October 16, 1992
    Product Code
    GHH
    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
    GHH Fibrin Split Products

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