ClearanceBrief
510(k) K201880 ยท NBW System, Test, Blood Glucose, Over The Counter

MultiSure GK Link Blood Glucose and Ketone Monitoring System

ApplicantApex BioTechnology Corp., Hsinchu, TW
DecisionSubstantially Equivalent, Oct 15, 2021
ReceivedJul 7, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K201880

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.