The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia Pr3s Immunoassay; Elia Mpos Immunoassay; Elia Gbm Immunoassay.
| Device ID | K173792 |
| 510k Number | K173792 |
| Device Name: | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| 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 | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2018-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066014166 | K173792 | 000 |