Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K141351 |
Device Name |
SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
Biotest Medical Corp. |
NO.3-2, CHIEN-KUO ROAD, TEPZ |
TANTZU |
TAICHUNG,
TW
42760
|
|
Applicant Contact |
Yuhua Chen |
Correspondent |
Biotest Medical Corp. |
NO.3-2, CHIEN-KUO ROAD, TEPZ |
TANTZU |
TAICHUNG,
TW
42760
|
|
Correspondent Contact |
Yuhua Chen |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/22/2014 |
Decision Date | 05/19/2015 |
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
|
|
|