510(k) K151935 ยท LYR Helicobacter Pylori
Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only
| Applicant | Alere San Diego, Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Aug 12, 2015 |
| Received | Jul 14, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151935
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.