ClearanceBrief
510(k) K252323 ยท PZI Prescription Use Blood Glucose Meter For Near-Patient Testing

cobas pulse blood glucose monitoring system

ApplicantRoche Diagnostics, Indianapolis IN, US
DecisionSubstantially Equivalent, Jun 12, 2026
ReceivedJul 25, 2025
TypeDual Track
FDA recordOpen on fda.gov

Recalls that name K252323

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.