510(k) K001177 ยท LYR Helicobacter Pylori
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
| Applicant | Enteric Products, Inc., Stony Brook NY, US |
| Decision | Substantially Equivalent, Nov 13, 2000 |
| Received | Apr 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001177
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.