K260026
- 510(k) number
- K260026
- Device name
- Tina-quant Cardiac high sensitivity CRP III
- Applicant
- Roche Diagnostics IN · US
- Product code
- NQD — Cardiac C-Reactive Protein, Antigen, Antiserum, And
- Decision date
- 2026-04-02
- Date received
- 2026-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260026.pdf
Official FDA record: K260026
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.