BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

    K Number: K042448 · Decision Oct 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    6
    Review Days
    50

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    Basic Information

    Device Name
    DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
    K Number
    K042448
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Atomics
    Date Received
    September 9, 2004
    Decision Date
    October 29, 2004
    Product Code
    JJX
    Advisory Committee
    Clinical Chemistry
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

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