The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia M2 Immunoassay.
| Device ID | K181556 |
| 510k Number | K181556 |
| Device Name: | EliA M2 Immunoassay |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | Phadia AB Rapsgatan 7P Uppsala, SE Se 754 50 |
| Contact | Carina Magnusson |
| Correspondent | Martin Robert Mann Phadia US Inc. 4169 Commercial Avenue Portage, MI 49002 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-13 |
| Decision Date | 2018-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066014333 | K181556 | 000 |
| 07333066020402 | K181556 | 000 |