510(k) K991803 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, May 5, 2000 |
| Received | May 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991803
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.