K251721
- 510(k) number
- K251721
- Device name
- Xpert GI Panel
- Applicant
- Cepheid CA · US
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2026-01-16
- Date received
- 2025-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K251721.pdf
Official FDA record: K251721
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.