ClearanceBrief
510(k) K092283 ยท DFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

ApplicantSiemens Healthcare Diagnostics, Newark DE, US
DecisionSubstantially Equivalent, Oct 21, 2009
ReceivedJul 29, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K092283

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.