ClearanceBrief
510(k) K183127 ยท LTT Panels, Test, Susceptibility, Antimicrobial

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)

ApplicantBeckman Coulter, Inc., West Sacramento CA, US
DecisionSubstantially Equivalent, Feb 12, 2019
ReceivedNov 13, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K183127

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.