K260047
- 510(k) number
- K260047
- Device name
- cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- PGX — Groups A, C And G Beta-Hemolytic Streptococcus Nucle
- Decision date
- 2026-08-28
- Date received
- 2026-01-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K260047.pdf
Official FDA record: K260047
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.