Polymer Technology Systems, Inc. is one of 5575 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Polymer Technology Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System, CardioChek Plus Test System, CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
27
Total
27
Cleared
0
Denied
Polymer Technology Systems, Inc. has 27 FDA 510(k) cleared chemistry devices. Based in Indianapolis, US.
Historical record: 27 cleared submissions from 1998 to 2016.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Polymer Technology Systems, Inc.
27 devices
Cleared
Dec 22, 2016
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test...
Chemistry
562d
Cleared
Jul 07, 2015
CardioChek Plus Test System
Chemistry
29d
Cleared
May 22, 2015
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
Chemistry
494d
Cleared
Oct 02, 2014
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System,...
Chemistry
45d
Cleared
Oct 15, 2007
PTS PANELS CHOL+HDL PANEL TEST STRIPS
Chemistry
126d
Cleared
Sep 10, 2007
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
Chemistry
101d
Cleared
Jan 31, 2007
PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
Chemistry
28d
Cleared
Apr 05, 2006
PTS PANELS HDL CHOLESTEROL TEST STRIPS
Chemistry
28d
Cleared
Jul 23, 2004
PTS PANELS CHOL+GLU TEST PANEL
Chemistry
24d
Cleared
Jul 06, 2004
PTS PANELS LDL CHOLESTEROL TEST STRIPS
Chemistry
111d
Cleared
Nov 15, 2002
PTS PANELS LIPID PANEL TEST STRIPS
Chemistry
23d
Cleared
Sep 24, 2002
PTS PANELS LIPID PANEL TEST STRIPS
Chemistry
21d