K220062
- 510(k) number
- K220062
- Device name
- QIAstat-Dx Gastrointestinal Panel 2
- Applicant
- QIAGEN GmbH DE
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2024-05-31
- Date received
- 2022-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K220062.pdf
Official FDA record: K220062
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.