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

    AUTO/STAT KIT

    K Number: K780512 · Decision May 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    10
    Review Days
    34

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    Basic Information

    Device Name
    AUTO/STAT KIT
    K Number
    K780512
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pierce Chemical Co.
    Date Received
    March 30, 1978
    Decision Date
    May 3, 1978
    Product Code
    CGA
    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
    CGA Glucose Oxidase, Glucose

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