510(k) K131330 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
| Applicant | Gold Standard Diagnostics, Davis CA, US |
| Decision | Substantially Equivalent, Jan 28, 2014 |
| Received | May 8, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131330
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.