510(k) K141274 · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 13, 2015 |
| Received | May 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141274
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.