510(k) K954106 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
THERATEST LAB, INC., EL-ANASCR KIT
| Applicant | Theratest Laboratories, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Nov 14, 1995 |
| Received | Aug 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954106
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.