ClearanceBrief
510(k) K060359 ยท JIT Calibrator, Secondary

ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10

ApplicantDenka Seiken Co., Ltd., Gosen-Shi, Niigata, JP
DecisionSubstantially Equivalent, Apr 14, 2006
ReceivedFeb 13, 2006
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K060359

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.