510(k) K983378 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.
| Applicant | Zeus Scientific, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Sep 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983378
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.