ClearanceBrief
510(k) K010858 ยท MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION

ApplicantId Biomedical Corp., Bothell WA, US
DecisionSubstantially Equivalent, May 24, 2001
ReceivedMar 22, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K010858

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.