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

    SERALYZER REFLECTANCE PHOTOMETER/CALIB.

    K Number: K800524 · Decision Apr 2, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    158
    Review Days
    27

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    Basic Information

    Device Name
    SERALYZER REFLECTANCE PHOTOMETER/CALIB.
    K Number
    K800524
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    March 6, 1980
    Decision Date
    April 2, 1980
    Product Code
    CIE
    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
    CIE Volumetric/Manometric, Carbon-Dioxide

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    K872634 CUTTER PUREFLO PLUS IV FILTER
    K870214 MODIFIED SALTEX REAGENT STRIPS
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