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

    SPECTROLYSE HEPARIN KIT

    K Number: K923499 · Decision Jan 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    13
    Review Days
    561

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    Basic Information

    Device Name
    SPECTROLYSE HEPARIN KIT
    K Number
    K923499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biopool AB
    Date Received
    July 15, 1992
    Decision Date
    January 27, 1994
    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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