Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K142302 |
Device Name |
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 Chemistry Panel Test System |
Applicant |
Polymer Technology Systems, Inc. |
7736 Zionsville Rd. |
Indianapolis,
IN
46268
|
|
Applicant Contact |
Jack Rogers |
Correspondent |
Polymer Technology Systems, Inc. |
7736 Zionsville Rd. |
Indianapolis,
IN
46268
|
|
Correspondent Contact |
Jack Rogers |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/18/2014 |
Decision Date | 10/02/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|