Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K171785 |
Device Name |
WowGoHealth Blood Glucose Monitoring System |
Applicant |
Biotest Medical Corporation |
No. 3-2, Chien-kuo Rd., TEPZ Tantzu dist. |
taichung,
TW
42760
|
|
Applicant Contact |
fred lee |
Correspondent |
Biotest Medical Corporation |
No. 3-2, Chien-kuo Rd. TEPZ Tantzu dist. |
taichung,
TW
42760
|
|
Correspondent Contact |
fred lee |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 06/15/2017 |
Decision Date | 09/15/2017 |
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
|
|
|