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MTM301 Blood Glucose and Ketone Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202534
510(k) Type
Traditional
Applicant
Apex Biotechnology Corp.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
4/6/2022
Days to Decision
582 days
Submission Type
Summary

MTM301 Blood Glucose and Ketone Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202534
510(k) Type
Traditional
Applicant
Apex Biotechnology Corp.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
4/6/2022
Days to Decision
582 days
Submission Type
Summary