Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K121654 |
Device Name |
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION |
Applicant |
i-SENS, Inc. |
465-6 WOLGYE-DONG, NOWON-GU |
SEOUL,
KR
139-845
|
|
Applicant Contact |
HYUN JOON OH |
Correspondent |
i-SENS, Inc. |
465-6 WOLGYE-DONG, NOWON-GU |
SEOUL,
KR
139-845
|
|
Correspondent Contact |
HYUN JOON OH |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/05/2012 |
Decision Date | 09/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|