The following data is part of a premarket notification filed by Eurospital S.p.a. with the FDA for Calprest Ng.
| Device ID | K160447 |
| 510k Number | K160447 |
| Device Name: | Calprest NG |
| Classification | Calprotectin, Fecal |
| Applicant | EUROSPITAL S.P.A. VIA FLAVIA 122 Trieste, IT 34147 |
| Contact | Claudia Brandolin |
| Correspondent | Catherine L. Wong CATHERINE L. WONG 2832 VIA PACHECO Palos Verdes Estates, CA 90274 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2016-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08028169204246 | K160447 | 000 |