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

    AHBD

    K Number: K822739 · Decision Oct 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    50
    Review Days
    39

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    Basic Information

    Device Name
    AHBD
    K Number
    K822739
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1380
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gilford Diagnostics
    Date Received
    September 9, 1982
    Decision Date
    October 18, 1982
    Product Code
    JMK
    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
    JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

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    K Number Device Name
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    K822149 GILCHEM Y-GT REAGENT
    K821719 AMMONIA REAGENT
    K820976 GIL CHEM MAGNESIUM REAGENT
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