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510(k) Data Aggregation

    K Number
    K983309
    Device Name
    SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
    Manufacturer
    ACCUMED INTL., INC.
    Date Cleared
    1998-12-14

    (84 days)

    Product Code
    LTT
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Levofloxacin in the dilution range of 0.004 - 8 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a susceptibility testing device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot extract the requested information from the provided text.

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