BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SEDIPLAST

    K Number: K840500 · Decision Feb 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    6
    Applicant Total
    3
    Review Days
    15

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    Basic Information

    Device Name
    SEDIPLAST
    K Number
    K840500
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Precision Technology, Inc.
    Date Received
    February 6, 1984
    Decision Date
    February 21, 1984
    Product Code
    JPH
    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
    JPH Test, Erythrocyte Sedimentation Rate

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