ClearanceBrief
510(k) K113809 ยท DCN System, Test, C-Reactive Protein

HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)

ApplicantHitachi Chemical Diagnostics, Inc., Los Angeles CA, US
DecisionSubstantially Equivalent, Aug 17, 2012
ReceivedDec 23, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K113809

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.