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510(k) Data Aggregation

    K Number
    K983306
    Device Name
    SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
    Manufacturer
    ACCUMED INTL., INC.
    Date Cleared
    1998-12-18

    (88 days)

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

    SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN

    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 Grepafloxacin in the difution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "indications for use" and the clinical significance of Grepafloxacin is unknown when evaluating Enterobacteriaceae, Pseudomonas, or any other non-fastidious gram negative rods.

    Device Description

    Susceptibility Test Panel

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

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