510(k) K983464 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Oct 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983464
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.