Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K173638 |
Device Name |
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus |
Applicant |
Bionime Corporation |
No. 100, Sec. 2, Daqing St., South Dist. |
Taichung,
TW
40242
|
|
Applicant Contact |
Kay Wu |
Correspondent |
Dynamic Biotech Inc. dba IVDD Regulatory Consultant |
29222 Rancho Viejo Road, Suite 218 |
San Juan Capistrano,
CA
92675
|
|
Correspondent Contact |
Feng-Yu Lee |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 11/24/2017 |
Decision Date | 08/17/2018 |
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
|
|
|