510(k) K110745 ยท LYR Helicobacter Pylori
HELICOBACTER PYLORI ELISA IGG TEST KIT
| Applicant | Gold Standard Diagnostics, Davis CA, US |
| Decision | Substantially Equivalent, Mar 2, 2012 |
| Received | Mar 17, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110745
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.