Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K091168 |
Device Name |
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 |
Applicant |
INFOPIA CO., LTD |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
MARIA F GRIFFIN |
Correspondent |
INFOPIA CO., LTD |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
MARIA F GRIFFIN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/22/2009 |
Decision Date | 05/27/2010 |
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
|
|
|