ClearanceBrief
510(k) K093032 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET

ApplicantBiosite Incorporated, San Diego CA, US
DecisionSubstantially Equivalent, Nov 13, 2009
ReceivedSep 29, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K093032

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.