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

    COULTER MULTI Q PREP

    K Number: K935953 · Decision Mar 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    13
    Applicant Total
    51
    Review Days
    88

    Basic Information

    Device Name
    COULTER MULTI Q PREP
    K Number
    K935953
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COULTER CORP.
    Date Received
    December 13, 1993
    Decision Date
    March 11, 1994
    Product Code
    GKH
    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
    GKH Apparatus, Automated Blood Cell Diluting

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