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

    SRT-SYSTEM

    K Number: K852554 · Decision Jul 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    31

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    Basic Information

    Device Name
    SRT-SYSTEM
    K Number
    K852554
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Microwave Development, Inc.
    Date Received
    June 17, 1985
    Decision Date
    July 18, 1985
    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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