K260917
- 510(k) number
- K260917
- Device name
- cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- QEP — Nucleic Acid Detection System For Non-Viral Microorg
- Decision date
- 2026-07-08
- Date received
- 2026-03-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K260917.pdf
Official FDA record: K260917
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.