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510(k) Data Aggregation

    K Number
    K994135
    Device Name
    HARDYDISK ERYTHROMYCIN, 15MCG
    Manufacturer
    HARDY DIAGNOSTICS
    Date Cleared
    2000-02-16

    (71 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K972418,K830206
    Why did this record match?
    Device Name :

    HARDYDISK ERYTHROMYCIN, 15MCG

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

    HardyDisk™ Antimicrobial Seasitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test proccdure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial vathogens. Standardized methods for agar diffusion testing have been described for Euterobacteriaccas, Staphylococcus spp., Pseudomonas spn., Acinetobacter spp., Listerta monocytogenes, Enterococcus spp., other streptococci and, hy modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

    Hardy Disk™ Erythromycin is indicated for in vitro activity against Staphylococcus spp., and Streptococcus spp. including S. pneumoniae.

    Device Description

    HardyDisk™ Erythromycin 15mcg is an antimicrobial sensitivity disk.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Hardy Diagnostics for their HardyDisk™ Erythromycin 15mcg. While it confirms the device's substantial equivalence to a predicate device and its regulatory classification, it does not contain the detailed study information or acceptance criteria requested.

    Therefore, I cannot provide a response filling out the requested table and study details. The document is primarily a regulatory approval letter and an "Indications for Use Statement."

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