ClearanceBrief
510(k) DEN200040 ยท QPO Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

OMNIgene GUT Dx

ApplicantDNA Genotek, Inc., Ottawa, CA
DecisionUnknown, Nov 3, 2021
ReceivedJun 15, 2020
TypeDirect
FDA recordOpen on fda.gov

Recalls that name DEN200040

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.