510(k) K170993 ยท NXO Calprotectin, Fecal
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 22, 2017 |
| Received | Apr 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170993
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.