510(k) K870453 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
DS-DNA EIA DIAGNOSTIC KIT
| Applicant | Biohytech International, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Mar 24, 1987 |
| Received | Jan 21, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870453
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.