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PAXgene® Blood DNA Tube

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231469
510(k) Type
Special
Applicant
Preanalytix GmbH
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
6/21/2023
Days to Decision
30 days
Submission Type
Summary

PAXgene® Blood DNA Tube

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231469
510(k) Type
Special
Applicant
Preanalytix GmbH
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
6/21/2023
Days to Decision
30 days
Submission Type
Summary