510(k) K980821 ยท LYR Helicobacter Pylori
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jul 30, 1998 |
| Received | Mar 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980821
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.