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VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222126
510(k) Type
Traditional
Applicant
Vivachek Biotech (Hangzhou) Co., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/16/2024
Days to Decision
760 days
Submission Type
Summary

VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222126
510(k) Type
Traditional
Applicant
Vivachek Biotech (Hangzhou) Co., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
8/16/2024
Days to Decision
760 days
Submission Type
Summary