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

    SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS

    K Number: K914022 · Decision Jan 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    7
    Review Days
    140

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    Basic Information

    Device Name
    SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS
    K Number
    K914022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pharmacia Diagnostics, Inc.
    Date Received
    September 9, 1991
    Decision Date
    January 27, 1992
    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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