510(k) K233058
- Device
- VivaChek Link Plus Blood Glucose Monitoring System
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- 510(k) number
- K233058
- Product code
- NBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-22
- Date received
- 2023-09-25
- Regulation
- 862.1345
- Classification name
- System, Test, Blood Glucose, Over The Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Mark Qian
- Address
- Level 2, Block 2, 146 E. Chaofeng Rd. Yuhang Economy Development Zone Hangzhou CN 311100 311100
FDA Registration Numbers
- 1450662
- 2030633
- 3012188053
- 3004009431
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- 1066444
- 3021286079
- 3013160357
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Source Documents
Other 510(k) Records For Product Code NBW
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| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | 2024-01-19 |
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| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | 2023-08-10 |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | 2023-08-10 |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | 2023-06-28 |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2022-12-21 |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | 2022-11-18 |