510(k) K112414 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Jun 22, 2012 |
| Received | Aug 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112414
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.