ClearanceBrief
510(k) K233242 · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)

ApplicantSiemens Healthcare Diagnostics, Inc., Newark DE, US
DecisionSubstantially Equivalent, Jan 18, 2024
ReceivedSep 28, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K233242

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.