FDA 510(k) Applications Submitted by POLYMER TECHNOLOGY SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K142302 |
08/18/2014 |
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemis |
Polymer Technology Systems, Inc. |
| K972669 |
07/16/1997 |
MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K070017 |
01/03/2007 |
PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K140068 |
01/13/2014 |
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K990247 |
01/26/1999 |
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K010456 |
02/16/2001 |
BIOSCANNER CREATININE TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K000586 |
02/22/2000 |
BIOSCANNER TRIGLYCERIDES TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K990688 |
02/25/1999 |
MTM BIOSCANNER C TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K060617 |
03/08/2006 |
PTS PANELS HDL CHOLESTEROL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K040693 |
03/17/2004 |
PTS PANELS LDL CHOLESTEROL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K981493 |
04/27/1998 |
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K981865 |
05/28/1998 |
MTM BIOSCANNER K TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K071507 |
06/01/2007 |
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K991894 |
06/03/1999 |
BIOSCANNER TRIGLYCERIDES TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K151545 |
06/09/2015 |
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K071593 |
06/11/2007 |
PTS PANELS CHOL+HDL PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K013068 |
06/28/2001 |
BIOSCANNER 2000 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K041750 |
06/29/2004 |
PTS PANELS CHOL+GLU TEST PANEL |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K022401 |
07/23/2002 |
PTS PANELS MULTI-CHEMISTRY CONTROLS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K022898 |
09/03/2002 |
PTS PANELS LIPID PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K013173 |
09/24/2001 |
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K013203 |
09/25/2001 |
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K993377 |
09/28/1999 |
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K023558 |
10/23/2002 |
PTS PANELS LIPID PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K983860 |
11/02/1998 |
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K014099 |
12/13/2001 |
BIOSCANNER PLUS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
| K151530 |
06/08/2015 |
CardioChek Plus Test System |
POLYMER TECHNOLOGY SYSTEMS, INC. |
|
|
