Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K140210 |
Device Name |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 |
Applicant |
BIONIME CORPORATION |
29222 RANCHO VIEJO ROAD |
SUITE 218 |
SAN JUN CAPISTRANO,
CA
92675
|
|
Applicant Contact |
Feng-Yu Lee |
Correspondent |
BIONIME CORPORATION |
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 | 01/28/2014 |
Decision Date | 08/22/2014 |
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
|
|
|