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

    GERMCO TEST R GLUCOSE TEST KIT

    K Number: K810567 · Decision Mar 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    8
    Review Days
    10

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    Basic Information

    Device Name
    GERMCO TEST R GLUCOSE TEST KIT
    K Number
    K810567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fermco Biochemics, Inc.
    Date Received
    March 3, 1981
    Decision Date
    March 13, 1981
    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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    Other Clearances by Fermco Biochemics, Inc.

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    K781945 GLUCOSE OXIDASE REAGENT