BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY

    K Number: K922801 · Decision Jan 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    19
    Review Days
    210

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    Basic Information

    Device Name
    RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
    K Number
    K922801
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3020
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Diagnostics
    Date Received
    June 10, 1992
    Decision Date
    January 6, 1993
    Product Code
    GNY
    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
    GNY Antisera, Fluorescent, Adenovirus 1-33

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