K242256
- 510(k) number
- K242256
- Device name
- QIAstat-Dx Meningitis/Encephalitis (ME) Panel
- Applicant
- QIAGEN GmbH DE
- Product code
- PLO — Meningitis/Encephalitis Pathogen Multiplex Nucleic A
- Decision date
- 2024-10-29
- Date received
- 2024-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K242256.pdf
Official FDA record: K242256
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.