The following data is part of a premarket notification filed by Eurospital S.p.a. with the FDA for Calprestng, Easycal.
| Device ID | K191592 |
| 510k Number | K191592 |
| Device Name: | CalprestNG, EasyCal |
| Classification | Calprotectin, Fecal |
| Applicant | Eurospital S.p.A. Via Flavia 122 Trieste, IT 34147 |
| Contact | Chiara Pelillo |
| Correspondent | Chiara Pelillo Eurospital S.p.A. Via Flavia 122 Trieste, IT 34147 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950913337 | K191592 | 000 |