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

    VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT

    K Number: K900688 · Decision May 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    30
    Review Days
    91

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    Basic Information

    Device Name
    VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
    K Number
    K900688
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Sciences, Inc.
    Date Received
    February 13, 1990
    Decision Date
    May 15, 1990
    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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    K883601 EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
    K874594 TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
    K872942 IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
    K860145 RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
    K860773 TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
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