510(k) K191592
- Device
- CalprestNG, EasyCal
- Applicant
- Eurospital S.p.A.
- 510(k) number
- K191592
- Product code
- NXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-10
- Date received
- 2019-06-14
- Regulation
- 866.5180
- Classification name
- Calprotectin, Fecal
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chiara Pelillo
- Address
- Via Flavia 122 Trieste IT 34147 34147
FDA Registration Numbers#
- 3005360469
- 2032900
- 2026994
- 2032839
- 1000191380
- 1222302
- 2182595
- 2029372
- 3011806823
- 9615139
Source Documents#
Other 510(k) Records For Product Code NXO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | 2024-02-06 |
| K220763 | ALPCO Calprotectin Immunoturbidimetric Assay | ALPCO | 2023-04-13 |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | DiaSorin, Inc. | 2022-07-26 |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | ALPCO | 2019-10-25 |
| K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | 2019-09-24 |
| K191589 | Calprest, EasyCal | Eurospital S.P.A. | 2019-07-10 |
| K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | 2019-06-25 |
| 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 |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Inova Diagnostics, Inc. | 2018-10-16 |
| K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | 2018-06-04 |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | Inova Diagnostics, Inc. | 2017-12-22 |
| K160447 | Calprest NG | Eurospital S.P.A. | 2016-11-10 |
| K130945 | CALPREST | Eurospital S.P.A. | 2014-01-16 |
| DEN060001 | PHICAL TEST | Genova Diagnostics | 2006-04-26 |
Legacy Summary#
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FDA Review#
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