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510(k) Data Aggregation

    K Number
    K971633
    Device Name
    PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    Manufacturer
    OXOID, LTD.
    Date Cleared
    1997-07-03

    (62 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

    Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriacae and Enterococcus spp., and by modified procedures, Haemophilus influenzae.

    Device Description

    Oxoid Piperacillin/Tazobactam Susceptibility Test Disc

    AI/ML Overview

    This document is a 510(k) submission for a Piperacillin/Tazobactam Antimicrobial Susceptibility Test Disc. It provides regulatory information and general indications for use, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory clearance letter.

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