510(k) K162788 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
| Applicant | Immco Diagnostics, Inc., Clarence NY, US |
| Decision | Substantially Equivalent, Jun 19, 2017 |
| Received | Oct 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162788
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.