510(k) K083080 ยท DHR System, Test, Rheumatoid Factor
IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
| Applicant | Sqi Diagnostics Systems, Toronto, On, CA |
| Decision | Substantially Equivalent, Oct 29, 2009 |
| Received | Oct 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083080
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.