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510(k) Data Aggregation

    K Number
    K021515
    Device Name
    EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2002-07-16

    (67 days)

    Product Code
    CHL,CEM,GKF,JFP,JGS
    Regulation Number
    862.1120
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER

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

    The EasyStat analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide), PQ2 (partial pressure of oxygen),Hct (Hematocrit), Na* (sodium), K' (potassium), and Ca* (ionized calcium) on whole blood samples from syringes or capillary tubes.

    This analyzer is used by laboratory trained technicians in the clinical laboratories to aide in the diagnosis and treatment of patients with electrolyte, blood gas and/or acid base disturbances. The patient results obtained from the EasyStat analyzer must be used in conjunction with the overall patient clinical condition before corrective / therapeutic action is taken.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the EasyStat pH, PCO2, PO2, Hct, Na+, K+, Ca++ Analyzer. It does not contain the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not publicly available in this FDA letter.

    Therefore, I cannot provide the requested information based on the provided text.

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