510(k) K982434 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
REAADS IGA ANTI-B2GP 1 TEST KIT
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Dec 22, 1998 |
| Received | Jul 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982434
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.