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

    SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

    K Number: K960366 · Decision Apr 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    49
    Applicant Total
    12
    Review Days
    75

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    Basic Information

    Device Name
    SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
    K Number
    K960366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Accumed Intl., Inc.
    Date Received
    January 25, 1996
    Decision Date
    April 9, 1996
    Product Code
    LTT
    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
    LTT Panels, Test, Susceptibility, Antimicrobial

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    Other Clearances by Accumed Intl., Inc.

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    K983310 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
    K983309 SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
    K983301 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
    K982786 TRACCELL 2000 SLIDE MAPPING SYSTEM
    K972576 GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
    K964689 TRACCELL 2000 SLIDE MAPPING SYSTEM
    K972756 MODIFICATION OF EST CULTURE SYSTEM II - MYCO
    K965190 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
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