Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K153286 |
Device Name |
iHealth Align Gluco-Monitoring system |
Applicant |
Andon health Co., Ltd |
No. 3 Jimping Street, Ya'am Road, Nankai District |
Tianjin,
CN
300190
|
|
Applicant Contact |
Yi Liu |
Correspondent |
Andon health Co., Ltd |
No. 3 Jimping Street, Ya'am Road, Nankai District |
Tianjin,
CN
300190
|
|
Correspondent Contact |
Yi Liu |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/12/2015 |
Decision Date | 08/19/2016 |
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
|
|
|