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510(k) Data Aggregation

    K Number
    K971640
    Device Name
    LEADCARE BLOOD LEAD TESTING SYSTEM
    Manufacturer
    ESA, INC.
    Date Cleared
    1997-09-09

    (130 days)

    Product Code
    DOF
    Regulation Number
    862.3550
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LEADCARE BLOOD LEAD TESTING SYSTEM

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

    The LEADCARE™ Blood Lead Testing System is an instrumented assay to be used in the quantitation of lead in human whole blood. The LEADCARE System is suitable for use in a physician office laboratory environment (POL).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a blood lead testing system. It acknowledges the device's substantial equivalence to previously marketed devices but does not contain any information regarding acceptance criteria, study details, or performance data.

    Therefore, I cannot answer your request based on the provided input. The document is a regulatory approval notice, not a technical study report.

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