510(k) K010858 ยท MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
| Applicant | Id Biomedical Corp., Bothell WA, US |
| Decision | Substantially Equivalent, May 24, 2001 |
| Received | Mar 22, 2001 |
| Type | Traditional |
| FDA record | Open 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.