ClearanceBrief
510(k) K120369 ยท CFR Hexokinase, Glucose

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)

ApplicantHitachi Chemical Diagnostics, Inc., Mountain View CA, US
DecisionSubstantially Equivalent, May 10, 2012
ReceivedFeb 6, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K120369

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.