510(k) K163538 · NBS Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 6, 2017 |
| Received | Dec 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163538
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.