K261867
- 510(k) number
- K261867
- Device name
- Xpert Carba-R
- Applicant
- Cepheid® CA · US
- Product code
- POC — System, Nucleic Acid Amplification Test, Dna, Antimi
- Decision date
- 2026-07-02
- Date received
- 2026-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261867.pdf
Official FDA record: K261867
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.