PAXgene® Blood DNA Tube— 510(k) K231469
Substantially EquivalentPreanalytix GmbH
FDA 510(k) clearance K231469 for PAXgene® Blood DNA Tube, Substantially Equivalent on 2023-06-21. Applicant: Preanalytix GmbH.
Clearance details
- Applicant
- Preanalytix GmbH
- Product code
- Code PJE
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hombrechtikon, CH
Adverse events under product code PJE
product code PJE- Malfunction
- 540
- Total
- 540
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.