ClearanceBrief
510(k) K250084 · LTT Panels, Test, Susceptibility, Antimicrobial

MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)

ApplicantBeckman Coulter, Inc., West Sacramento CA, US
DecisionSubstantially Equivalent, Jul 18, 2025
ReceivedJan 13, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250084

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.