510(k) K955085 ยท LYR Helicobacter Pylori
HM-CAP EIA TEST (MODIFICATION)
| Applicant | Schiff & Co., West Cadwell NJ, US |
| Decision | Substantially Equivalent, Feb 9, 1996 |
| Received | Oct 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955085
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.