510(k) K914853 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT
| Applicant | Reads Medical Products, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Jan 15, 1992 |
| Received | Oct 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914853
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.