The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Ro52, Elia Ro60.
| Device ID | K210902 |
| 510k Number | K210902 |
| Device Name: | EliA Ro52, EliA Ro60 |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | Phadia AB Rapsgatan 7P Uppsala, SE |
| Contact | Sheryl Skinner |
| Correspondent | Jane R Anthony Phadia, US Lnc. 4169 Commercial Avenue Portage, MI 49002 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-26 |
| Decision Date | 2022-07-27 |