FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
K Number: K222126
·
Decision Aug 16, 2024
Classifications
1
FEI Numbers
177
Registration Numbers
178
Same Product Code
506
Applicant Total
3
Review Days
760
Basic Information
- Device Name
- VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
- K Number
- K222126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd
- Date Received
- July 18, 2022
- Decision Date
- August 16, 2024
- Product Code
- NBW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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