ClearanceBrief
510(k) K061338 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)

DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY

ApplicantDade Behring, Inc., Newark DE, US
DecisionSubstantially Equivalent, Jul 6, 2006
ReceivedMay 15, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K061338

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.