510(k) clearance
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)
- 510(k) number
- K260045
- Applicant
- Roche Molecular Systems, Inc.
- Decision date
- Aug 28, 2026
- Date received
- Jan 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OZN
- Device type
- C. Difficile Toxin Gene Amplification Assay
- Device class
- Class II
- Regulation
- 21 CFR 866.3130
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Pleasanton, CA, US