510(k) K001460 ยท LYR Helicobacter Pylori
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
| Applicant | bioMerieux, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Oct 4, 2000 |
| Received | May 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001460
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.