LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991108
    Device Name
    CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (54 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    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 carbon dioxide reagent (CO2), product No. CO107-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of CO2 inserum or plasma.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a Carbon Dioxide reagent. It grants clearance for marketing but does not contain information about acceptance criteria or a study proving the device meets them. This document is a regulatory approval and not a performance study report. Therefore, I cannot extract the requested information from this text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1