The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Celikey Igg Immunoassay; Elia Gliadindp Iga Immunoassay; Elia Gliadindp Igg Immunoassay.
| Device ID | K181871 |
| 510k Number | K181871 |
| Device Name: | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| 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 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2019-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066014180 | K181871 | 000 |