|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
cardiochek plus test system, cardiochek home test system
|
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
|
K162282 |
12/22/2016
|
cardiochek plus test system; cardiochek plus home test system
|
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
|
K193406 |
02/26/2022
|
bioscanner 2000
|
POLYMER TECHNOLOGY SYSTEMS, INC.
|
K013068 |
11/20/2001
|
bioscanner beyond glucose analyzer and test strips
|
POLYMER TECHNOLOGY SYSTEMS, INC.
|
K013203 |
11/16/2001
|
bioscanner plus
|
POLYMER TECHNOLOGY SYSTEMS, INC.
|
K014099 |
12/21/2001
|
cardiochek plus test system, cardiochek home test system
|
POLYMER TECHNOLOGY SYSTEMS, INC.
|
K140068 |
05/22/2015
|
pts panels chol+glu test panel
|
POLYMER TECHNOLOGY SYSTEMS, INC.
|
K041750 |
07/23/2004
|
pts panels chol+hdl+glu panel test strips
|
POLYMER TECHNOLOGY SYSTEMS, INC.
|
K071507 |
09/10/2007
|
pts panels metabolic chemistry panel test strips
|
POLYMER TECHNOLOGY SYSTEMS, INC.
|
K070017 |
01/31/2007
|