The following data is part of a premarket notification filed by Phadia Ab with the FDA for Elia B2-glycoprotein I Iga Immunoassay, Elia Cardiolipin Iga Immunoassay.
| Device ID | K181329 |
| 510k Number | K181329 |
| Device Name: | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| 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 | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-18 |
| Decision Date | 2018-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066014197 | K181329 | 000 |