ClearanceBrief
510(k) K081319 ยท JIT Calibrator, Secondary

DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

ApplicantSiemens Healthcare Diagnostics, Inc., Newark DE, US
DecisionSubstantially Equivalent, Aug 4, 2008
ReceivedMay 12, 2008
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K081319

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.