Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K161738 |
Device Name |
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems |
Applicant |
TAIDOC TECHNOLOGY CORPORATION |
6F, NO.127, WUGONG 2ND RD., WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Applicant Contact |
PAUL LIU |
Correspondent |
TAIDOC TECHNOLOGY CORPORATION |
6F, NO.127, WUGONG 2ND RD., WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Correspondent Contact |
PAUL LIU |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/23/2016 |
Decision Date | 11/10/2016 |
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
|
|
|