BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CardioChek Home Chol+HDL+GLU Test Strip

    Reg #: 3015525148 · FEI: 3002698769 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Polymer Technology Systems
    Registration Number
    3015525148
    FEI Number
    3002698769
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4600 Anson Boulevard
    City
    Whitestown
    State
    IN
    ZIP
    46075
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162282

    Owner / Operator

    Firm Name
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Operator Number
    9031081
    Address
    4600 Anson Blvd.
    City
    Whitestown
    State
    IN
    Postal Code
    46075
    Country
    US

    Products

    Device Name Product Code
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Ldl & Vldl Precipitation, Hdl LBR

    Proprietary Names

    CardioChek Home Chol+HDL+GLU Test Strip CardioChek Plus Test System PTS Panels Chol+HDL Test Strip PTS Panels Chol+HDL+GLU Test Strip CardioChek Home Test System CardioChek Plus analyzer CardioChek Home Chol+GLU Test Strip CardioChek Home Analyzer PTS Panels Chol+GLU Test Strip CardioChek Home Chol+HDL Test Strip

    Establishment Types

    Manufacture Medical Device