510(k) K950110 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
MARDX MITOCHONDRIA EIA TEST SYSTEM
| Applicant | Hogan & Hartson, Washington, D.C. DC, US |
| Decision | Substantially Equivalent, May 15, 1995 |
| Received | Jan 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950110
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.