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

    STAK-CHEX

    K Number: K911582 · Decision May 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    11
    Applicant Total
    70
    Review Days
    50

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    Basic Information

    Device Name
    STAK-CHEX
    K Number
    K911582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Streck Laboratories, Inc.
    Date Received
    April 8, 1991
    Decision Date
    May 28, 1991
    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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