ClearanceBrief
510(k) K250003 ยท PZM Next Generation Sequencing Based Tumor Profiling Test

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

ApplicantGeneseeq Technology, Inc., Toronto, CA
DecisionSubstantially Equivalent, Aug 29, 2025
ReceivedJan 2, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250003

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.