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

    FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339

    K Number: K871284 · Decision Apr 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    66
    Applicant Total
    56
    Review Days
    8

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    Basic Information

    Device Name
    FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339
    K Number
    K871284
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Research Products Co.
    Date Received
    March 31, 1987
    Decision Date
    April 8, 1987
    Product Code
    JIY
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JIY Photometric Method, Iron (Non-Heme)

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