510(k) K030775 ยท LKJ Antinuclear Antibody, Antigen, Control
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
| Applicant | Immuno Concepts, N.A. , Ltd., Dallas TX, US |
| Decision | Substantially Equivalent, May 12, 2003 |
| Received | Mar 11, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K030775
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.