510(k) K011400 ยท MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
MRSA-SCREEN
| Applicant | Denka Seiken'S, Tokyo, JP |
| Decision | Substantially Equivalent, Mar 27, 2002 |
| Received | May 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011400
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.