ClearanceBrief
510(k) K103044 ยท NBW System, Test, Blood Glucose, Over The Counter

AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

ApplicantBestgen Biotech Corp., Jung-He, Taipei County, TW
DecisionSubstantially Equivalent, Feb 10, 2012
ReceivedOct 14, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K103044

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.