510(k) K090755 ยท OPN Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
QUANTA LITE APS/PT IGG AND IGM ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 1, 2010 |
| Received | Mar 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090755
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.