The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Cenp Immunoassay, Elia U1rnp Immunoassay, Elia Rnp70 Immunoassay.
| Device ID | K182353 |
| 510k Number | K182353 |
| Device Name: | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | Phadia AB Rapsgatan 7P Uppsala, SE Se 754 50 |
| Contact | Carina Magnusson |
| Correspondent | Sheryl Skinner Phadia US Inc. 4169 Commercial Avenue Portage, MI 49002 -9701 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-29 |
| Decision Date | 2018-11-27 |
| Summary: | summary |