QIAstat-Dx Meningitis/Encephalitis (ME) Panel— 510(k) K242256
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K242256 for QIAstat-Dx Meningitis/Encephalitis (ME) Panel, Substantially Equivalent on 2024-10-29. Applicant: QIAGEN GmbH.
Clearance details
- Applicant
- QIAGEN GmbH
- Product code
- Code PLO
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hilden, DE
Adverse events under product code PLO
product code PLO- Death
- 5
- Total
- 5
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.