ClearanceBrief
510(k) K221813 ยท CGX Alkaline Picrate, Colorimetry, Creatinine

Nova Allegro UACR Assay, Nova Allegro Analyzer

ApplicantNova Biomedical Corporation, Walham MA, US
DecisionSubstantially Equivalent, Nov 19, 2024
ReceivedJun 22, 2022
TypeDual Track
FDA recordOpen on fda.gov

Recalls that name K221813

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.