510(k) K800605 ยท DHC System, Test, Systemic Lupus Erythematosus
ANA LATEX SLIDE TEST
| Applicant | Biologics Intl., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 2, 1980 |
| Received | Mar 17, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800605
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.