FDA 510(k) Applications Submitted by Margo Enright
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
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. |
K162282 |
08/15/2016 |
CardioChek Plus Test System, CardioChek Home Test System |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
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. |
K193406 |
12/09/2019 |
CardioChek Plus Test System; CardioChek Plus Home Test System |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
K014099 |
12/13/2001 |
BIOSCANNER PLUS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
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