510(k) K982879 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Oct 15, 1998 |
| Received | Aug 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982879
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2005 | Diasorin Inc. Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Terminated |
MSV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.