ClearanceBrief
510(k) K030801 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL

ApplicantBayer Healthcare, LLC, Tarrytown NY, US
DecisionSubstantially Equivalent, Apr 9, 2003
ReceivedMar 13, 2003
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K030801

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.