K242109
- 510(k) number
- K242109
- Device name
- Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
- Applicant
- Cepheid® CA · US
- Product code
- QQX — Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Decision date
- 2025-01-15
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K242109.pdf
Official FDA record: K242109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.