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

    REDI-DISC HEMOGLOBIN GEL TUBE KIT

    K Number: K780163 · Decision Mar 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    158
    Review Days
    55

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    Basic Information

    Device Name
    REDI-DISC HEMOGLOBIN GEL TUBE KIT
    K Number
    K780163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7440
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    January 31, 1978
    Decision Date
    March 27, 1978
    Product Code
    JBD
    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
    JBD System, Analysis, Electrophoretic Hemoglobin

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