K243753
- 510(k) number
- K243753
- Device name
- cobas liat Bordetella panel nucleic acid test
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- OZZ — Bordetella Pertussis Dna Assay System
- Decision date
- 2025-11-20
- Date received
- 2024-12-05
- 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: K243753.pdf
Official FDA record: K243753
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.