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510(k) Data Aggregation

    K Number
    K993994
    Device Name
    HARDYDISK AZITHROMYCIN 15MCG
    Manufacturer
    HARDY DIAGNOSTICS
    Date Cleared
    1999-12-21

    (27 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" Autuniciplial Seusitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and ccrtain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., I seudomonas spp., Acinetobacter spp., Listeria monocylogenes, Enterococcus spp., other streptococci and, by modified procedures, Ilaemophilus influenzae, Neisseria gonorrhoeae and Streptococcus preumoniae.

    Hardy Disker Azithromycin is indicated for Staphylococcus spp., Streptococcus spp., including S. pncumoniae, and Haemophilus spp.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for the HardyDisk™ Azithromycin 15mcg, a device used for semi-quantitative in vitro susceptibility testing. The letter determines substantial equivalence to a predicate device but does not contain the detailed study information or acceptance criteria requested.

    Therefore, I cannot provide the requested information from the provided document. The document primarily focuses on regulatory clearance based on substantial equivalence, rather than a detailed performance study report.

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