|
Document Number | K102751 |
Test Name | Green Cross Medis Corp. LabonaCheck Gluppy Blood Glucose Monitoring System |
Manufacturer Name | CERAGEM MEDISYS INC. |
Consumer Information Phone Number | 1(800)903-9333 |
Test Type | Glucose monitoring devices (FDA cleared/home use) |
Effective Date | 06/11/2015 |
| |
Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K102751 |
Device Name |
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
CERAGEM MEDISYS INC. |
3699 WILSHIRE BLVD., STE 930 |
LOS ANGELES,
CA
90010
|
|
Applicant Contact |
GRACE KIM |
Correspondent |
CERAGEM MEDISYS INC. |
3699 WILSHIRE BLVD., STE 930 |
LOS ANGELES,
CA
90010
|
|
Correspondent Contact |
GRACE KIM |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/23/2010 |
Decision Date | 02/11/2013 |
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
|
|
|
|