FDA 510(k) Applications for Medical Device Product Code "NXO"
(Calprotectin, Fecal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K191807 | ALPCO | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | 10/25/2019 |
| K220763 | ALPCO | ALPCO Calprotectin Immunoturbidimetric Assay | 04/13/2023 |
| K181012 | BUHLMANN Laboratories AG | BUHLMANN fCAL ELISA | 06/04/2018 |
| K190784 | BUHLMANN Laboratories AG | BUHLMANN fCAL turbo | 06/25/2019 |
| K191718 | BUHLMANN Laboratories AG | Buhlmann fCAL turbo and CALEX Cap | 09/24/2019 |
| K182698 | DiaSorin Inc. | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device | 12/26/2018 |
| K213858 | DiaSorin Inc. | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | 07/26/2022 |
| K130945 | EUROSPITAL S.P.A. | CALPREST | 01/16/2014 |
| K160447 | EUROSPITAL S.P.A. | Calprest NG | 11/10/2016 |
| K191589 | Eurospital S.p.A. | Calprest, EasyCal | 07/10/2019 |
| K191592 | Eurospital S.p.A. | CalprestNG, EasyCal | 07/10/2019 |
| DEN060001 | GENOVA DIAGNOSTICS | PHICAL TEST | 04/26/2006 |
| K180971 | Inova Diagnostics, Inc. | QUANTA Flash Calprotectin and Fecal Extraction Device | 10/16/2018 |
| K170993 | Inova Diagnostics, Inc. | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | 12/22/2017 |
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