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

    ASSAY, CHROMOGENIC ANTITHROMBIN III

    K Number: K781860 · Decision Dec 4, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    24
    Review Days
    28

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    Basic Information

    Device Name
    ASSAY, CHROMOGENIC ANTITHROMBIN III
    K Number
    K781860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostics, Inc.
    Date Received
    November 6, 1978
    Decision Date
    December 4, 1978
    Product Code
    JBQ
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    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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