Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K231476 |
Device Name |
TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System |
Applicant |
Sinocare Inc. |
No.265 Guyuan Road, Hi-Tech Zone, Changsha, Hunan Province |
Changsha,
CN
410205
|
|
Applicant Contact |
Qian Zhou |
Correspondent |
Sinocare Inc. |
No.265 Guyuan Road, Hi-Tech Zone, Changsha, Hunan Province |
Changsha,
CN
410205
|
|
Correspondent Contact |
Lingjia Zhu |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 05/22/2023 |
Decision Date | 12/01/2023 |
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
|
|
|