ClearanceBrief
510(k) K260026 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Tina-quant Cardiac high sensitivity CRP III

ApplicantRoche Diagnostics, Indianapolis IN, US
DecisionSubstantially Equivalent, Apr 2, 2026
ReceivedJan 5, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260026

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.