510(k) K993557 ยท DHR System, Test, Rheumatoid Factor
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Mar 3, 2000 |
| Received | Oct 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993557
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.