510(k) K000463 ยท LYR Helicobacter Pylori
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jun 1, 2000 |
| Received | Feb 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2003 | Diagnostic Products Corp Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit) Terminated |
LYR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.