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

    SICKLE-CHECK

    K Number: K820037 · Decision Feb 4, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    28
    Review Days
    28

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    Basic Information

    Device Name
    SICKLE-CHECK
    K Number
    K820037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Technology, Inc.
    Date Received
    January 7, 1982
    Decision Date
    February 4, 1982
    Product Code
    JCM
    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
    JCM Control, Hemoglobin, Abnormal

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