BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CHLAMYDIA IGG ELISA TEST SYSTEM

    K Number: K962558 · Decision Feb 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    68
    Review Days
    238

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    Basic Information

    Device Name
    CHLAMYDIA IGG ELISA TEST SYSTEM
    K Number
    K962558
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Armkel, LLC
    Date Received
    July 1, 1996
    Decision Date
    February 24, 1997
    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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