BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator

    K Number: K150412 · Decision Aug 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    43
    Review Days
    191

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    Basic Information

    Device Name
    Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
    K Number
    K150412
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site Group , Ltd.
    Date Received
    February 18, 2015
    Decision Date
    August 28, 2015
    Product Code
    DAE
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DAE Complement C9, Antigen, Antiserum, Control

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