510(k) K031177 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jun 19, 2003 |
| Received | Apr 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031177
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.