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

    VZV IGG ELISA TEST

    K Number: K941046 · Decision Aug 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    57
    Review Days
    535

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    Basic Information

    Device Name
    VZV IGG ELISA TEST
    K Number
    K941046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gull Laboratories, Inc.
    Date Received
    March 7, 1994
    Decision Date
    August 24, 1995
    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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