FDA 510(k) clearance · back to tracker

cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems

Roche Molecular Systems, Inc. cleared K260917 on 2026-07-08, decision: substantially equivalent

K-number

K260917

Sponsor

Roche Molecular Systems, Inc.

Device

cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-08

Product code

QEP

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3393

Official FDA record

Open K260917on accessdata.fda.gov →

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

openFDA JSON

Raw record →

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.