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

    SERAQUEST VZV IGG

    K Number: K972295 · Decision Nov 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    25
    Review Days
    139

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    Basic Information

    Device Name
    SERAQUEST VZV IGG
    K Number
    K972295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Quest Intl., Inc.
    Date Received
    June 19, 1997
    Decision Date
    November 5, 1997
    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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