510(k) K961784 ยท LQN Latex Agglutination Assay, Rubella
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
| Applicant | Sienna Biotech, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Oct 31, 1996 |
| Received | May 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961784
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.