510(k) K000879 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, May 22, 2000 |
| Received | Mar 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000879
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.