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Xprecia Prime Coagulation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230802
510(k) Type
Dual Track
Applicant
Universal Biosensors Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
3/15/2024
Days to Decision
358 days
Submission Type
Summary

Xprecia Prime Coagulation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230802
510(k) Type
Dual Track
Applicant
Universal Biosensors Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
3/15/2024
Days to Decision
358 days
Submission Type
Summary