510(k) K983655 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
AUTOSTAT II ANA SCREEN ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Jan 28, 1999 |
| Received | Oct 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983655
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.