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

    CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE

    K Number: K934497 · Decision Dec 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    11
    Applicant Total
    79
    Review Days
    83

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    Basic Information

    Device Name
    CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
    K Number
    K934497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    R&D Systems, Inc.
    Date Received
    September 14, 1993
    Decision Date
    December 6, 1993
    Product Code
    JCN
    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
    JCN Control, Cell Counter, Normal And Abnormal

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