510(k) K143754 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 21, 2015 |
| Received | Dec 31, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143754
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.