510(k) K013077 ยท MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | Sep 14, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013077
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.