ClearanceBrief
510(k) K252206 ยท CGX Alkaline Picrate, Colorimetry, Creatinine

Nova Allegro UACR Assay, Nova Allegro Analyzer

ApplicantNova Biomedical Corporation, Walham MA, US
DecisionSubstantially Equivalent, Jan 9, 2026
ReceivedJul 14, 2025
TypeDual Track
FDA recordOpen on fda.gov

Recalls that name K252206

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.