ClearanceBrief
510(k) K030089 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS

ApplicantBiosite Incorporated, San Diego CA, US
DecisionSubstantially Equivalent, Jan 23, 2003
ReceivedJan 10, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K030089

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.