510(k) K971537 ยท LYR Helicobacter Pylori
PYLORISET EIA-G (68926)
| Applicant | Orion Diagnostica, Div. Orion Corp., Espoo, FI |
| Decision | Substantially Equivalent, Jun 27, 1997 |
| Received | Apr 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971537
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.