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510(k) Data Aggregation

    K Number
    K994051
    Device Name
    HARDYDISK DOXYCYCLINE, 30MCG
    Manufacturer
    HARDY DIAGNOSTICS
    Date Cleared
    2000-01-10

    (41 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HardyDisk™ Antimichobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Sundardized methods for agar diffusion testing have been described for Enterotaciacae, Stuphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterocccus spp., other streptococci and, by modified procedures, Huemophilus influenque, Neisseria gonorrhoeae and Streptococcus pneumoniae.

    HardyDisk™ Doxycycline are indicated for in vitro activity against the Enterobacteriaciae, Acinetobacter spp., Staphylococcus spp., and Enterococcus spp.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a HardyDisk™ Doxycycline 30mcg. This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

    The document is a regulatory approval notice that states the device is "substantially equivalent" to legally marketed predicate devices. It does not include performance data, study designs, sample sizes, or information about ground truth establishment.

    Therefore, I cannot provide the requested information based on this text.

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