510(k) K030702 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Sep 9, 2003 |
| Received | Mar 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030702
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.