BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    DCL MICROALBUMIN ASSAY, MODEL 252-20

    K Number: K051191 · Decision Jul 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    36
    Applicant Total
    66
    Review Days
    56

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    Basic Information

    Device Name
    DCL MICROALBUMIN ASSAY, MODEL 252-20
    K Number
    K051191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5040
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Chemicals , Ltd.
    Date Received
    May 10, 2005
    Decision Date
    July 5, 2005
    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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