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

    SPECTROLYSE HEPARIN (ANTI-IIA)

    K Number: K972209 · Decision Aug 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    57
    Review Days
    62

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    Basic Information

    Device Name
    SPECTROLYSE HEPARIN (ANTI-IIA)
    K Number
    K972209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Diagnostic Technologies, Inc.
    Date Received
    June 11, 1997
    Decision Date
    August 12, 1997
    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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