Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K092052 |
Device Name |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 |
Applicant |
BIONIME CORPORATION |
55 NORTHERN BLVD. SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
BIONIME CORPORATION |
55 NORTHERN BLVD. SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/07/2009 |
Decision Date | 06/18/2010 |
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
|
|
|