LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020852
    Device Name
    POLY-CHEM GLUCOSE
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2002-07-03

    (110 days)

    Product Code
    CFR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POLY-CHEM GLUCOSE

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

    The Polymedco Poly-Chem Glucose test system is an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma on the Poly-Chem analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of the pancreatic isle cell carcinoma.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "The Polymedco Poly-Chem Glucose Test" device. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, it does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The letter only states the device name, regulation number, regulatory class, product code, and indications for use. It confirms that the device can be marketed.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1