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

    ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT

    K Number: K863490 · Decision Nov 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    126
    Review Days
    57

    Basic Information

    Device Name
    ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
    K Number
    K863490
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    ORTHO DIAGNOSTIC SYSTEMS, INC.
    Date Received
    September 9, 1986
    Decision Date
    November 5, 1986
    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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