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

    STAK-CHEX PLUS RETICS

    K Number: K992887 · Decision Nov 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    9
    Applicant Total
    70
    Review Days
    87

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    Basic Information

    Device Name
    STAK-CHEX PLUS RETICS
    K Number
    K992887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Streck Laboratories, Inc.
    Date Received
    August 27, 1999
    Decision Date
    November 22, 1999
    Product Code
    GLQ
    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
    GLQ Mixture, Control, White-Cell And Red-Cell Indices

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