ClearanceBrief
510(k) K251564 ยท GJS Test, Time, Prothrombin

microINR System

ApplicantIline Microsystems, S.L., Donostia, ES
DecisionSubstantially Equivalent, Jul 21, 2025
ReceivedMay 22, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251564

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.