510(k) K181329 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jun 25, 2018 |
| Received | May 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181329
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.