510(k) K063565 ยท OBE Anti-Ss-A 52 Autoantibodies
QUANTA LITE SS-A 52 ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 4, 2007 |
| Received | Nov 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063565
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.