ClearanceBrief
510(k) K213887 ยท NBW System, Test, Blood Glucose, Over The Counter

GAL-1A Plus Blood Glucose Monitoring System

ApplicantApex BioTechnology Corp., Hsinchu, CN
DecisionSubstantially Equivalent, Mar 29, 2022
ReceivedDec 13, 2021
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K213887

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.