510(k) K213858 ยท NXO Calprotectin, Fecal
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Jul 26, 2022 |
| Received | Dec 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2024 | Diasorin Inc. DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens Open, Classified |
NXO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.