510(k) K955481 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
THERATEST KIT (MODIFICATION)
| Applicant | Theratest Laboratories, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Mar 6, 1996 |
| Received | Nov 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955481
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.