510(k) K942908 ยท DHR System, Test, Rheumatoid Factor
IGM RF EIA
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jan 20, 1995 |
| Received | Jun 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942908
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.