510(k) K953686 ยท LYR Helicobacter Pylori
HELISAL RAPID BLOOD TEST
| Applicant | Cortecs, Ltd., West Cadwell NJ, US |
| Decision | Substantially Equivalent, May 21, 1996 |
| Received | Jul 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953686
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.