510(k) K000535 ยท NBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
QUANTA LITE LKM-1 ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 7, 2000 |
| Received | Feb 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000535
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.