510(k) K141655 ยท OBE Anti-Ss-A 52 Autoantibodies
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 5, 2015 |
| Received | Jun 20, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141655
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.