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

    2487 DUAL WAVELENGTH ABSORBANCE DETECTOR

    K Number: K973074 · Decision Oct 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
    K Number
    K973074
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Waters Corporation
    Date Received
    August 18, 1997
    Decision Date
    October 6, 1997
    Product Code
    KZR
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KZR Chromatography (Liquid, Gel), Clinical Use

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