510(k) K091556 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, May 21, 2010 |
| Received | May 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091556
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.