ClearanceBrief
510(k) K260812 ยท SGA Biothreat Microbial Agent Nucleic Acid Detection Test

Francisella tularensis Real-time PCR Assay

ApplicantCenters for Disease Control and Prevention, Atlanta GA, US
DecisionSubstantially Equivalent, Mar 30, 2026
ReceivedMar 13, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K260812

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.