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

    ELISA COMBI-KIT HUMAN IGG SUBCLASSES

    K Number: K911610 · Decision Jun 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    75
    Applicant Total
    1
    Review Days
    79

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    Basic Information

    Device Name
    ELISA COMBI-KIT HUMAN IGG SUBCLASSES
    K Number
    K911610
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Janssen Research Foundation
    Date Received
    March 25, 1991
    Decision Date
    June 12, 1991
    Product Code
    DEW
    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
    DEW Igg, Antigen, Antiserum, Control

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