BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Polymer Technology Systems

    Reg #: 3015525148 · FEI: 3002698769 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    68
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    Polymer Technology Systems
    Registration Number
    3015525148
    FEI Number
    3002698769
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4600 Anson Boulevard
    City
    Whitestown
    State
    IN
    ZIP
    46075
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070017

    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
    Ldl & Vldl Precipitation, Hdl LBR
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Test, Triglycerides, Over The Counter NGO
    Lipoprotein, High Density, Hdl, Over The Counter NAQ
    Colorimetric Method, Triglycerides JGY
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Tube, Collection, Capillary Blood GIO
    Medical Device Data System OUG
    Assay, Glycosylated Hemoglobin LCP
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    PTS PANELS Metabolic Chemistry Panel Test Strips CardioChek PA Analyzer CardioChek Plus Analyzer PTS Panels Metabolic Chemistry Test Strips PTS PANELS HDL Cholesterol Test Strips CardioChek Analyzer PTS Panels Triglycerides Test Strip CardioChek Home Test System CardioChek Plus Test System CardioChek PA Test System CardioChek PA Home Test System PTS PANELS Triglycerides Test Strips PTS PANELS CHOL+HDL Panel Test Strips CardioChek PA PTS PANELS CHOL+HDL+GLU Panel Test Strips CardioChek Plus PTS Panels CHOL+HDL+GLU Test Strips PTS PANELS CHOL+GLU Panel Test Strips PTS Panels CHOL+GLU Test Strips PTS PANELS Multi-Chemistry Controls PTS PANELS HDL Cholesterol Controls CardioChek Home Chol+HDL+GLU Test Strip CardioChek Plus analyzer CardioChek Home Chol+GLU Test Strip PTS Panels Chol+HDL Test Strip PTS Panels Chol+GLU Test Strip CardioChek Home Chol+HDL Test Strip PTS Panels Chol+HDL+GLU Test Strip CardioChek Home Analyzer PTS Diagnostics Capillary Tubes PTS Collect Capillary Tubes CardioChek Link CardioChek Link Software PTS Connect Dock PTS Connect Universal Solution PTS Connect adapter PTS PANELS Cholesterol Test Strips PTS Panels Cholesterol Self-Test Strips PTS PANELS Lipid Panel Test Strips CardioChek Plus Lipid+eGLU Test Strips Smart Bundle Pack CardioChek + A1CNow+ Professional Use A1CNow Self Check Walgreens At-Home A1C Test Kit ReliOn A1C Self-Test System A1CNow+ Professional Use (A1CNow+ Monitor; A1CNow+ Test Cartridge; A1CNow+ Dilution Kit) CVS Health At Home A1C Test Kit True+ A1CNow Self Check PTS Panels Cholesterol Test Strip PTS Panels Total Cholesterol Test Strip PTS Panels eGLU Test Strips PTS Panels Glucose Test Strips CardioChek Plus Home Chol+Glu test strips PTS Panels eGlu test strips CardioChek Plus Home eGlu test strips PTS Panels Chol+Glu test strips PTS Panels Chol+HDL+Glu test strips PTS Panels Chol+HDL test strips CardioChek Home CardioChek Plus Home Chol+HDL test strips CardioChek Plus Home Lipid Panel test strips CardioChek Plus Home Chol+HDL+Glu test strips PTS Panels Lipid Panel test strips CardioChek ChekMate Strips CardioChek ChekMate PTS PANELS Glucose Test Strips PTS A1CNow+ Controls PTS Panels Lipid Panel Test Strips

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility