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

    RAICHEM TM HEMOGLOBIN REAGENT

    K Number: K896922 · Decision Jan 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    63
    Review Days
    45

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    Basic Information

    Device Name
    RAICHEM TM HEMOGLOBIN REAGENT
    K Number
    K896922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Reagents Applications, Inc.
    Date Received
    December 11, 1989
    Decision Date
    January 25, 1990
    Product Code
    GKK
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GKK Cyanomethemoglobin

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