Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K151595 |
Device Name |
On Call Express Pro Blood Glucose Monitoring System |
Applicant |
ACON Laboratories, Inc. |
10125 Mesa Rim Road |
San Diego,
CA
92121
|
|
Applicant Contact |
Qiyi Xie |
Correspondent |
ACON Laboratories, Inc. |
10125 Mesa Rim Road |
San Diego,
CA
92121
|
|
Correspondent Contact |
Qiyi Xie |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/12/2015 |
Decision Date | 09/05/2015 |
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
|
|
|