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510(k) Data Aggregation

    K Number
    K024006
    Device Name
    G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2003-03-31

    (117 days)

    Product Code
    JBF
    Regulation Number
    864.7360
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

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

    For the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification acceptance letter and an Indications for Use statement for a medical device. It does not contain information about acceptance criteria, study details, or device performance as requested in the prompt. Therefore, I cannot provide the requested information based on this input.

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