ClearanceBrief
510(k) K152556 ยท OYJ Dna Specimen Collection, Saliva

Oragene Dx

ApplicantDNA Genotek, Inc., Ottawa, CA
DecisionSubstantially Equivalent, May 26, 2016
ReceivedSep 8, 2015
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K152556

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.