510(k) K990915 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
| Applicant | Stellar Bio Systems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Apr 21, 1999 |
| Received | Mar 18, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990915
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.