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

    VARICELISA TEST KIT

    K Number: K823805 · Decision May 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    12
    Review Days
    139

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    Basic Information

    Device Name
    VARICELISA TEST KIT
    K Number
    K823805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    M.A. Bioproducts
    Date Received
    December 17, 1982
    Decision Date
    May 5, 1983
    Product Code
    LFY
    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
    LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

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    Other Clearances by M.A. Bioproducts

    K Number Device Name
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    K830615 CYTOMEGELISA STAT
    K821967 CHLAMYDELISA TEST KIT
    K821762 MEASELISA TEST KIT
    K813221 TOXOELISA TEST KIT
    K812531 CELL CULTURE REAGENTS
    K812123 CYTOMEGELISA TEST KIT
    K802508 RUBELISA IGM TEST KIT
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