K260045
- 510(k) number
- K260045
- Device name
- cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- OZN — C. Difficile Toxin Gene Amplification Assay
- Decision date
- 2026-08-28
- Date received
- 2026-01-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260045.pdf
Official FDA record: K260045
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.