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

    CYTOMEGALOVIRUS ANTOBODY IGG

    K Number: K822606 · Decision Nov 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    16
    Applicant Total
    15
    Review Days
    66

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    Basic Information

    Device Name
    CYTOMEGALOVIRUS ANTOBODY IGG
    K Number
    K822606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immulok, Inc.
    Date Received
    August 27, 1982
    Decision Date
    November 1, 1982
    Product Code
    LIN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

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