The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Calprotectin, Liaison Q.s.e.t. Device Plus.
| Device ID | K213858 |
| 510k Number | K213858 |
| Device Name: | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus |
| Classification | Calprotectin, Fecal |
| Applicant | DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 |
| Contact | Christa Blaisdell |
| Correspondent | Christa Blaisdell DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-10 |
| Decision Date | 2022-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056771602884 | K213858 | 000 |