510(k) K021482 ยท NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 30, 2002 |
| Received | May 8, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021482
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.