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

    CYTOMEGALOVIRUS IGG EIA TEST KIT

    K Number: K862705 · Decision Oct 1, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    17
    Applicant Total
    17
    Review Days
    77

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    Basic Information

    Device Name
    CYTOMEGALOVIRUS IGG EIA TEST KIT
    K Number
    K862705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Labsystems, Inc.
    Date Received
    July 16, 1986
    Decision Date
    October 1, 1986
    Product Code
    GQI
    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
    GQI Antiserum, Cf, Cytomegalovirus

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    Other Clearances by Labsystems, Inc.

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    K890154 MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
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    K881243 RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
    K873780 MODIFICATION RUBELLA IGM EIA TEST KIT
    K873583 AUTO-EIA
    K872252 MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT
    K862431 RUBELLA IGM EIA TEST KIT
    K862216 TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
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