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

    SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100

    K Number: K082251 · Decision Apr 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    36
    Applicant Total
    270
    Review Days
    243

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
    K Number
    K082251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5040
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    August 8, 2008
    Decision Date
    April 8, 2009
    Product Code
    DCF
    Advisory Committee
    Immunology
    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
    DCF Albumin, Antigen, Antiserum, Control

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