510(k) K990462 ยท LYR Helicobacter Pylori
IS H. PYLORI IGG ELISA TEST SYSTEM
| Applicant | Columbia Bioscience, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Sep 3, 1999 |
| Received | Feb 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990462
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.