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

    SICKLE CELL REAGENT SET

    K Number: K860420 · Decision Feb 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    17
    Applicant Total
    41
    Review Days
    20

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    Basic Information

    Device Name
    SICKLE CELL REAGENT SET
    K Number
    K860420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7825
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sterling Diagnostics, Inc.
    Date Received
    February 4, 1986
    Decision Date
    February 24, 1986
    Product Code
    GHM
    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
    GHM Test, Sickle Cell

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