Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K132663 |
Device Name |
I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
ALLIANCE INTERNATIONAL CO., LTD. |
NO.54 YING TAO RD. |
YING DISTRICT |
NEW TAIPEI CITY, 239,
TW
23942
|
|
Applicant Contact |
JEN KE-MIN |
Correspondent |
ALLIANCE INTERNATIONAL CO., LTD. |
NO.54 YING TAO RD. |
YING DISTRICT |
NEW TAIPEI CITY, 239,
TW
23942
|
|
Correspondent Contact |
JEN KE-MIN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/26/2013 |
Decision Date | 04/20/2015 |
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
|
|
|