BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    SEROELISA(TM) CHLAMYDIA IGA TEST KIT

    K Number: K914327 · Decision Jun 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    5
    Review Days
    256

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    Basic Information

    Device Name
    SEROELISA(TM) CHLAMYDIA IGA TEST KIT
    K Number
    K914327
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Savyon Diagnostics , Ltd.
    Date Received
    September 27, 1991
    Decision Date
    June 9, 1992
    Product Code
    LJC
    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
    LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

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