K243455
- 510(k) number
- K243455
- Device name
- cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2025-07-31
- Date received
- 2024-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243455.pdf
Official FDA record: K243455
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.