K240197
- 510(k) number
- K240197
- 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
- 2025-01-16
- Date received
- 2024-01-25
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240197.pdf
Official FDA record: K240197
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.