510(k) K852033 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
| Applicant | Meloy Laboratories, Inc., Springfield VA, US |
| Decision | Substantially Equivalent, Jun 21, 1985 |
| Received | May 9, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852033
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.