510(k) K000534 ยท DHR System, Test, Rheumatoid Factor
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 5, 2000 |
| Received | Feb 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000534
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.