The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Calprotectin, Liaison Calprotectin Control Set, Liaison Calprotectin Calibration Verifiers, Liaison Q.s.e.t. Buffer, Liaison Q.s.e.t. Device.
| Device ID | K182698 |
| 510k Number | K182698 |
| Device Name: | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device |
| Classification | Calprotectin, Fecal |
| Applicant | DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
| Contact | John C. Walter |
| Correspondent | Sandra Zimniewicz DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2018-12-26 |
| Summary: | summary |