ClearanceBrief
510(k) K110701 ยท OYJ Dna Specimen Collection, Saliva

ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500

ApplicantDNA Genotek, Inc., Ottawa Ontario, CA
DecisionSubstantially Equivalent, Dec 2, 2011
ReceivedMar 14, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K110701

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.