Clearance Summary
PAXgene® Blood DNA Tube received FDA 510(k) clearance under submission number K231469, sponsored by Preanalytix GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2023-06-21.
- Submission: K231469
- Applicant / Sponsor: Preanalytix GmbH
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2023-06-21
Classification & Regulation
This clearance is catalogued under FDA product code PJE and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.