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

    YSI MODELS 23C & 23CM HDL & TOTAL CHOLES

    K Number: K801285 · Decision Jul 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    229
    Applicant Total
    23
    Review Days
    60

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    Basic Information

    Device Name
    YSI MODELS 23C & 23CM HDL & TOTAL CHOLES
    K Number
    K801285
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Yellow Springs Instrument Co., Inc.
    Date Received
    May 29, 1980
    Decision Date
    July 28, 1980
    Product Code
    CHH
    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
    CHH Enzymatic Esterase--Oxidase, Cholesterol

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