510(k) K910033 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
UBI MAGIWEL(TM) ANA QUANTITATIVE
| Applicant | United Biotech, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jan 25, 1991 |
| Received | Jan 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910033
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.