510(k) K993635 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
MDI SM/RNP TEST
| Applicant | Micro Detect, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, Jan 10, 2000 |
| Received | Oct 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993635
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.