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

    RAICHEM X-HBDH REAGENT

    K Number: K843774 · Decision Oct 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    63
    Review Days
    36

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    Basic Information

    Device Name
    RAICHEM X-HBDH REAGENT
    K Number
    K843774
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1380
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Reagents Applications, Inc.
    Date Received
    September 25, 1984
    Decision Date
    October 31, 1984
    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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