Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K162282 |
Device Name |
CardioChek Plus Test System, CardioChek Home Test System |
Applicant |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
7736 Zionsville Road |
Indianapolis,
IN
46268
|
|
Applicant Contact |
Margo Enright |
Correspondent |
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics |
7736 Zionsville Road |
Indianapolis,
IN
46268
|
|
Correspondent Contact |
Margo Enright |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/15/2016 |
Decision Date | 12/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|