ClearanceBrief
510(k) K080712 ยท MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167

ApplicantSerim Research Corp., Elkhart IN, US
DecisionSubstantially Equivalent, May 6, 2008
ReceivedMar 13, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K080712

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.