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

    ROCHE LACTATE ANALYZER 640

    K Number: K790421 · Decision May 15, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    26
    Applicant Total
    16
    Review Days
    76

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    Basic Information

    Device Name
    ROCHE LACTATE ANALYZER 640
    K Number
    K790421
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1450
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Roche Medical Electronics, Inc.
    Date Received
    February 28, 1979
    Decision Date
    May 15, 1979
    Product Code
    KHP
    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
    KHP Acid, Lactic, Enzymatic Method

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