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

    NEPHELOMETER

    K Number: K780251 · Decision Apr 6, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    13
    Applicant Total
    92
    Review Days
    51

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    Basic Information

    Device Name
    NEPHELOMETER
    K Number
    K780251
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    February 14, 1978
    Decision Date
    April 6, 1978
    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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