ClearanceBrief
510(k) K111996 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2

ApplicantElitechgroup, Bothell WA, US
DecisionSubstantially Equivalent, Sep 14, 2011
ReceivedJul 13, 2011
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K111996

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.