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

    HSVI - IGG ELISA-KIT

    K Number: K852782 · Decision Jan 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    30
    Review Days
    204

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    Basic Information

    Device Name
    HSVI - IGG ELISA-KIT
    K Number
    K852782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Sciences, Inc.
    Date Received
    July 1, 1985
    Decision Date
    January 21, 1986
    Product Code
    GQO
    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
    GQO Antisera, Cf, Herpesvirus Hominis 1,2

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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
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