510(k) K031208 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Jul 7, 2003 |
| Received | Apr 17, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031208
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.