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

    GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY

    K Number: K850486 · Decision May 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    50
    Review Days
    90

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    Basic Information

    Device Name
    GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
    K Number
    K850486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Warner-Lambert Co.
    Date Received
    February 7, 1985
    Decision Date
    May 8, 1985
    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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