510(k) K961169 ยท DHR System, Test, Rheumatoid Factor
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Jun 26, 1996 |
| Received | Mar 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961169
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.