Source document or public record
FDA 510(k) K231469 — PAXgene® Blood DNA Tube
FDA 510(k) index record K231469. Device: PAXgene® Blood DNA Tube. Applicant as listed: Preanalytix GmbH. Decision date: 2023-06-21.
Source
"device_name": "PAXgene® Blood DNA Tube"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K231469.
Device name: PAXgene® Blood DNA Tube. Applicant as listed: Preanalytix GmbH.
Decision date: 2023-06-21. Decision wording: Substantially Equivalent.
Product code: PJE. Regulation: 21 CFR 862.1675. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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