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510(k) Data Aggregation

    K Number
    K982528
    Manufacturer
    Date Cleared
    1998-09-09

    (51 days)

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

    Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. Nafcillin Susceptibility Test Discos are only for use with Staphylococcus spp.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter for a medical device: "Nafcillin Antimicrobial Susceptibility Test Disc." This document grants clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information typically found in a clinical study report or a 510(k) summary that would describe acceptance criteria and performance data.

    Therefore, I cannot provide the requested information from the given text. A 510(k) clearance letter confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate, allowing it to be marketed. It does not typically include the full scientific evidence or study details.

    To answer your request, I would need access to the actual 510(k) submission summary or a separate clinical study report for the "Nafcillin Antimicrobial Susceptibility Test Disc."

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