Polymer Technology Systems

FDA Device Registration & Listing · Whitestown, IN, US · Registration 3015525148

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015525148
FEI Number
3002698769
Entity Name
Polymer Technology Systems
City/State/Country
Whitestown, IN, US
Establishment Address
4600 Anson Boulevard, Whitestown, IN 46075, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
POLYMER TECHNOLOGY SYSTEMS, INC. (Owner Number: 9031081)
Owner / Operator Contact Address
4600 Anson Blvd., Whitestown, IN 46075, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K014099
PMA Number
N/A

All Registered 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 CardioChek Plus Analyzer CardioChek PA Analyzer CardioChek Plus Analyzer CardioChek PA Analyzer PTS Panels Triglycerides Test Strip CardioChek Analyzer CardioChek Home Test System CardioChek Plus Test System CardioChek PA Test System CardioChek PA Home Test System CardioChek PA Analyzer CardioChek Analyzer PTS PANELS Triglycerides Test Strips CardioChek Plus Analyzer CardioChek Plus Analyzer PTS PANELS CHOL+HDL Panel Test Strips CardioChek PA Analyzer CardioChek PA PTS PANELS CHOL+HDL+GLU Panel Test Strips CardioChek Plus PTS Panels CHOL+HDL+GLU Test Strips CardioChek PA Analyzer PTS PANELS CHOL+GLU Panel Test Strips CardioChek Plus Analyzer 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 CardioChek Plus Test System PTS Panels Chol+GLU Test Strip CardioChek Home Chol+HDL Test Strip PTS Panels Chol+HDL+GLU Test Strip CardioChek Home Test System 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 CardioChek Analyzer PTS PANELS Cholesterol Test Strips CardioChek Plus Analyzer CardioChek PA Analyzer PTS Panels Cholesterol Self-Test Strips PTS PANELS Lipid Panel Test Strips CardioChek Plus Lipid+eGLU Test Strips Smart Bundle Pack CardioChek PA Analyzer CardioChek Plus Analyzer CardioChek Plus Analyzer CardioChek + CardioChek Plus 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 CardioChek Analyzer CardioChek PA Analyzer CardioChek Plus Analyzer PTS Panels Cholesterol Test Strip PTS Panels Total Cholesterol Test Strip PTS Panels eGLU Test Strips CardioChek Plus Analyzer CardioChek Plus Lipid+eGLU Test Strips Smart Bundle Pack PTS Panels Glucose Test Strips CardioChek Analyzer CardioChek PA Analyzer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2007-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-11-08
NGO Test, Triglycerides, Over The Counter Clinical Chemistry Class 1 862.1705 2007-11-08
NAQ Lipoprotein, High Density, Hdl, Over The Counter Clinical Chemistry Class 1 862.1175 2007-11-08
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2007-11-08
NAQ Lipoprotein, High Density, Hdl, Over The Counter Clinical Chemistry Class 1 862.1175 2013-05-14
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2013-05-14
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2016-05-02
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2018-02-12
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2018-02-12
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2018-02-12
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2013-05-14
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2007-11-07
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2007-11-07
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-11-08
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2007-11-08
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2007-11-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2007-11-08
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2007-11-08
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2007-11-08
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2005-12-12
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2018-02-12
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2018-02-12
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2018-02-12
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2018-02-12
GIO Tube, Collection, Capillary Blood Hematology Class 1 864.6150 2015-01-21
OUG Medical Device Data System General Hospital Class 1 880.6310 2015-01-22
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2013-05-14
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2007-11-08
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2007-11-08
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2007-11-08
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2016-05-02
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2016-05-02
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-05-02
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2016-05-02
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2016-05-02
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2014-01-31
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2016-05-02
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2013-05-22
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2013-05-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

POLYMER TECHNOLOGY SYSTEMS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K811074 Reagents Applications, Inc. GLUCOSE REAGENT-ENZYMATIC-COLOR 500 1981-04-29
K936212 Heraeus Kulzer, Inc. GLUCOFILM TEST STRIPS 1994-05-10
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K790947 Macomb Chemical Co. AUTO ENZYMATIC CHOLESTEROL 1979-06-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000
Z-2165-2011 Instrumentation Laboratory Co. 2
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015525148. Last updated year: 2026. Please use registration number 3015525148 when referencing this establishment in official correspondence.
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