K253759
- 510(k) number
- K253759
- Device name
- cobas liat CT/NG/MG nucleic acid test
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- QEP — Nucleic Acid Detection System For Non-Viral Microorg
- Decision date
- 2026-05-15
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253759.pdf
Official FDA record: K253759
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.