Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K233058 |
Device Name |
VivaChek Link Plus Blood Glucose Monitoring System |
Applicant |
VivaChek Biotech (Hangzhou) Co., Ltd. |
Level 2, Block 2, 146 East Chaofeng Rd. |
Yuhang Economy Development Zone |
Hangzhou,
CN
311100
|
|
Applicant Contact |
Mark Qian |
Correspondent |
VivaChek Biotech (Hangzhou) Co., Ltd. |
Level 2, Block 2, 146 East Chaofeng Rd. |
Yuhang Economy Development Zone |
Hangzhou,
CN
311100
|
|
Correspondent Contact |
Mark Qian |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 09/25/2023 |
Decision Date | 12/22/2023 |
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
|
|
|