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

    ALBUMIN NEPHELOMETRIC ASSAY

    K Number: K801362 · Decision Jul 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    13
    Applicant Total
    54
    Review Days
    42

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    Basic Information

    Device Name
    ALBUMIN NEPHELOMETRIC ASSAY
    K Number
    K801362
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    June 9, 1980
    Decision Date
    July 21, 1980
    Product Code
    JQX
    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
    JQX Nephelometer, For Clinical Use

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