Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K141292 |
Device Name |
Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System |
Applicant |
BIONIME COPORATION |
29222 RANCHO VIEJO ROAD, SUITE 218 |
SAN JUN CAPISTRANO,
CA
92675
|
|
Applicant Contact |
Feng-Yu Lee |
Correspondent |
BIONIME COPORATION |
29222 RANCHO VIEJO ROAD, SUITE 218 |
SAN JUN CAPISTRANO,
CA
92675
|
|
Correspondent Contact |
Feng-Yu Lee |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/19/2014 |
Decision Date | 06/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|