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

    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

    K Number: K053243 · Decision Jan 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    44
    Applicant Total
    56
    Review Days
    60

    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
    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
    K Number
    K053243
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trek Diagnostic Systems, Inc.
    Date Received
    November 21, 2005
    Decision Date
    January 20, 2006
    Product Code
    LRG
    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
    LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

    Similar 510(k) Clearances

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

    Thermo Scientific Sensititre ARIS HiQ System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Thermo Scientific Sensititre ARIS HiQ System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SENSITITRE OPTIREAD

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUTOREADER 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROSCAN(R) MICROSTREP PLUS(R)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROSCAN (R) MICROSTREP PLUS (R) PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Trek Diagnostic Systems, Inc.

    K Number Device Name
    K093865 SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
    K090968 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
    K083606 SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
    K081063 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
    K081520 SENSITITRE VIZION
    K073653 SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
    K073558 SENSITITRE 18-24 SUSCEPTIBILITY PLATE
    K073424 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
    K062841 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES
    K062839 MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
    Search all 56 clearances from Trek Diagnostic Systems, Inc. →