510(k) K941509 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Jun 30, 1994 |
| Received | Mar 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941509
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.