Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K120423 |
Device Name |
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 |
Applicant |
BIONIME CORPORATION |
2700 LAPAZ ROAD |
SUITE 266B |
MISSION VIEJO,
CA
92691
|
|
Applicant Contact |
Feng-Yu Lee |
Correspondent |
BIONIME CORPORATION |
2700 LAPAZ ROAD |
SUITE 266B |
MISSION VIEJO,
CA
92691
|
|
Correspondent Contact |
Feng-Yu Lee |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/13/2012 |
Decision Date | 08/03/2012 |
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
|
|
|