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

    GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY

    K Number: K850412 · Decision May 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    50
    Review Days
    93

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    Basic Information

    Device Name
    GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
    K Number
    K850412
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Warner-Lambert Co.
    Date Received
    February 4, 1985
    Decision Date
    May 8, 1985
    Product Code
    JBQ
    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
    JBQ Antithrombin Iii Quantitation

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