ClearanceBrief
510(k) K124021 ยท CGA Glucose Oxidase, Glucose

ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM

ApplicantArkray Factory, Inc., Edina MN, US
DecisionSubstantially Equivalent, Jun 30, 2014
ReceivedDec 27, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K124021

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.