K240867
- 510(k) number
- K240867
- Device name
- cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- QQX — Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
- Decision date
- 2025-02-11
- Date received
- 2024-03-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240867.pdf
Official FDA record: K240867
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.