BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    SYNERMED SERUM IRON REAGENT KIT

    K Number: K902918 · Decision Jul 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    20
    Applicant Total
    45
    Review Days
    28

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    Basic Information

    Device Name
    SYNERMED SERUM IRON REAGENT KIT
    K Number
    K902918
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Synermed, Inc.
    Date Received
    July 3, 1990
    Decision Date
    July 31, 1990
    Product Code
    CFM
    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
    CFM Bathophenanthroline, Colorimetry, Iron (Non-Heme)

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    K953395 SYNERMED CALCIUM REAGENT KIT
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