ClearanceBrief
510(k) K082091 ยท GKZ Counter, Differential Cell

TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00

ApplicantReametrix, Inc., San Carlos CA, US
DecisionSubstantially Equivalent, Apr 15, 2009
ReceivedJul 24, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K082091

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.