K250324
- 510(k) number
- K250324
- Device name
- QIAstat-Dx GI Panel 2 Mini B
- Applicant
- QIAGEN GmbH DE
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2025-02-28
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250324.pdf
Official FDA record: K250324
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.