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

    HEMOLAB HEPARICHROM ASSAY

    K Number: K934274 · Decision May 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    49
    Review Days
    248

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    Basic Information

    Device Name
    HEMOLAB HEPARICHROM ASSAY
    K Number
    K934274
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerieux Vitek, Inc.
    Date Received
    August 31, 1993
    Decision Date
    May 6, 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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