ClearanceBrief
510(k) K091460 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087

ApplicantAmerican Biological Technologies, Inc., Seguin TX, US
DecisionSubstantially Equivalent, Aug 6, 2009
ReceivedMay 18, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K091460

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.