ClearanceBrief
510(k) K110641 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL

ApplicantFujirebio Diagnostics,Inc., Seguin TX, US
DecisionSubstantially Equivalent, May 27, 2011
ReceivedMar 4, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K110641

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.