510(k) K914550 ยท LKJ Antinuclear Antibody, Antigen, Control
ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
| Applicant | Diagnostic Resources, Inc., Aurora CO, US |
| Decision | Substantially Equivalent, Feb 11, 1992 |
| Received | Oct 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914550
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.