Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K122525 |
Device Name |
SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
Biotest Medical Corp. |
NO.3-2, CHIEN-KUO ROAD, TEPZ |
TANTZU |
TAICHUNG,
TW
427
|
|
Applicant Contact |
AMANDA CHIANG |
Correspondent |
Biotest Medical Corp. |
NO.3-2, CHIEN-KUO ROAD, TEPZ |
TANTZU |
TAICHUNG,
TW
427
|
|
Correspondent Contact |
AMANDA CHIANG |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/20/2012 |
Decision Date | 05/02/2013 |
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
|
|
|