FDA Product Code
FDA Product Code NXO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5180
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | 2024-02-06 | Special | PDF ↗ |
| K220763 | ALPCO Calprotectin Immunoturbidimetric Assay | ALPCO | 2023-04-13 | Traditional | PDF ↗ |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | DiaSorin, Inc. | 2022-07-26 | Traditional | PDF ↗ |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | ALPCO | 2019-10-25 | Traditional | PDF ↗ |
| K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | 2019-09-24 | Traditional | PDF ↗ |
| K191589 | Calprest, EasyCal | Eurospital S.P.A. | 2019-07-10 | Special | PDF ↗ |
| K191592 | CalprestNG, EasyCal | Eurospital S.P.A. | 2019-07-10 | Special | PDF ↗ |
| K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | 2019-06-25 | Traditional | PDF ↗ |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device | DiaSorin, Inc. | 2018-12-26 | Traditional | PDF ↗ |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Inova Diagnostics, Inc. | 2018-10-16 | Traditional | PDF ↗ |
| K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | 2018-06-04 | Traditional | PDF ↗ |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | Inova Diagnostics, Inc. | 2017-12-22 | Traditional | PDF ↗ |
| K160447 | Calprest NG | Eurospital S.P.A. | 2016-11-10 | Traditional | PDF ↗ |
| K130945 | CALPREST | Eurospital S.P.A. | 2014-01-16 | Traditional | PDF ↗ |
| DEN060001 | PHICAL TEST | Genova Diagnostics | 2006-04-26 | Post-NSE | — |
Product code NXO · Class II · Immunology. Data: openFDA.