Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K151164 |
Device Name |
Assure Prism multi Blood Glucose Monitoring System |
Applicant |
i-Sens, Inc. |
43, BANPO-DAERO 28-GIL, SEOCHO-GU |
SEOUL,
KR
137-873
|
|
Applicant Contact |
JOON HO JUNG |
Correspondent |
i-Sens, Inc. |
43, BANPO-DAERO 28-GIL, SEOCHO-GU |
SEOUL,
KR
137-873
|
|
Correspondent Contact |
JOON HO JUNG |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 05/01/2015 |
Decision Date | 08/07/2015 |
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
|
|
|