ClearanceBrief
510(k) K171742 ยท DFH Kappa, Antigen, Antiserum, Control

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

ApplicantSiemens Healthcare Diagnostics Products GmbH, Marburg, DE
DecisionSubstantially Equivalent, Nov 17, 2017
ReceivedJun 12, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K171742

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.