The following data is part of a premarket notification filed by Sentinel Ch. Srl with the FDA for Sentinel Ceruloplasmin.
| Device ID | K051456 |
| 510k Number | K051456 |
| Device Name: | SENTINEL CERULOPLASMIN |
| Classification | Indirect Copper Assay, Ceruloplasmin |
| Applicant | SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO Milano, IT 20155 |
| Contact | Davide Spada |
| Correspondent | Davide Spada SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO Milano, IT 20155 |
| Product Code | JFR |
| CFR Regulation Number | 866.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-02 |
| Decision Date | 2005-10-21 |
| Summary: | summary |