510(k) K946218 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
MARDX ENA EIA TEST SYSTEM
| Applicant | Hogan & Hartson, Washington, D.C. DC, US |
| Decision | Substantially Equivalent, May 15, 1995 |
| Received | Dec 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946218
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.