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

    ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

    K Number: K020914 · Decision May 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    280
    Review Days
    63

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    Basic Information

    Device Name
    ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
    K Number
    K020914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helena Laboratories
    Date Received
    March 21, 2002
    Decision Date
    May 23, 2002
    Product Code
    JBP
    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
    JBP Activated Whole Blood Clotting Time

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