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

    BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE

    K Number: K883776 · Decision Feb 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    150

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE
    K Number
    K883776
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Btc Corp.
    Date Received
    September 6, 1988
    Decision Date
    February 3, 1989
    Product Code
    LKI
    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
    LKI Antisera, Fluorescent, Chlamydia Spp.

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LKI), ordered by most recent decision date.

    IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LUPUS(LE)-LATEX TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHLAMYDIA (LGV-1)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CULUTURE SET CHLAMYDIA ISOLATION AND

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all