cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more— 510(k) K260045
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K260045 for cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more, Substantially Equivalent on 2026-08-28. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code OZN
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