The following data is part of a premarket notification filed by Eurospital S.p.a. with the FDA for Calprest.
| Device ID | K130945 |
| 510k Number | K130945 |
| Device Name: | CALPREST |
| Classification | Calprotectin, Fecal |
| Applicant | EUROSPITAL S.P.A. 3331 EAGLE WATCH DRIVE Woodstock, GA 30189 |
| Contact | David Dunn |
| Correspondent | David Dunn EUROSPITAL S.P.A. 3331 EAGLE WATCH DRIVE Woodstock, GA 30189 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-04 |
| Decision Date | 2014-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08028169204093 | K130945 | 000 |