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

    CD8 CYTOSPHERES KIT

    K Number: K923951 · Decision Apr 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    101
    Review Days
    627

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    Basic Information

    Device Name
    CD8 CYTOSPHERES KIT
    K Number
    K923951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coulter Electronics, Inc.
    Date Received
    August 6, 1992
    Decision Date
    April 25, 1994
    Product Code
    MAM
    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
    MAM Dna-Probe, B And T Lymphocyte

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