K260021
- 510(k) number
- K260021
- Device name
- cobas® BV/CV
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- PQA — Vaginitis And Bacterial Vaginosis Nucleic Acid Detec
- Decision date
- 2026-07-16
- Date received
- 2026-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260021.pdf
Official FDA record: K260021
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.