FDA 510(k) clearance · back to tracker

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)

Roche Molecular Systems, Inc. cleared K260045 on 2026-08-28, decision: substantially equivalent

K-number

K260045

Sponsor

Roche Molecular Systems, Inc.

Device

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)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-28

Product code

OZN

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3130

Official FDA record

Open K260045on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.