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510(k) Data Aggregation

    K Number
    K991870
    Device Name
    ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-07-30

    (59 days)

    Product Code
    CGZ,CEM,JGS
    Regulation Number
    862.1170
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03

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

    The ISE Electrolyte (Na+, K+ and Cl-) reagents, product No. 114-01, 1114-02 and 114-03 are intended for Invitro Diagnostic use in the automated, quantitative determination of sodium, potassium and chloride in serum, or plasma.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an "ISE Electrolytes" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process and the substantial equivalence determination.

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