ClearanceBrief
510(k) K251249 ยท GKZ Counter, Differential Cell

Tru Hematology Test

ApplicantTruvian Sciences, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Jan 16, 2026
ReceivedApr 23, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251249

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.