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510(k) Data Aggregation

    K Number
    K052485
    Device Name
    SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
    Manufacturer
    MIDI, INC.
    Date Cleared
    2006-01-17

    (130 days)

    Product Code
    NWZ,KZQ,NPO
    Regulation Number
    866.3045
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MIDI Sherlock Microbial Identification System for BioDef™ is intended to aid in the identification of Bacillus anthracis through the analysis of membrane fatty acids derived from cultured bacterial samples, using gas chromatography and pattern recognition software.

    Device Description

    Not Found

    AI/ML Overview

    The provided document does not contain information about the acceptance criteria and the study that proves the MIDI Sherlock Microbial Identification System BioDef™ meets these criteria. The document is an FDA 510(k) clearance letter confirming substantial equivalence to a predicate device and provides "Indications for Use" for the device, along with some warnings.

    Therefore, I cannot provide the requested information.

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