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510(k) Data Aggregation

    K Number
    K014295
    Device Name
    STAT PROFILE PHOX ANALYZER
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Date Cleared
    2002-02-28

    (62 days)

    Product Code
    CHL,GKR,JIX,JKS,JPI,JPK
    Regulation Number
    862.1120
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care users in the quantitative determination of pH, pCO2, pO2, sO2 %, Na+, K+, Cl-, iCa++, Glucose, Lactate, Hematocrit and Hemoglobin in whole blood. Whole blood pH, pCO2, and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Stat Profile pHOx Analyzer." It primarily discusses regulatory approval and does NOT contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request for this specific document. To provide the requested information, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed device submission.

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