510(k) K034013 ยท LKJ Antinuclear Antibody, Antigen, Control
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Jan 8, 2004 |
| Received | Dec 24, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K034013
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.