510(k) K081716 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
ADVIA CENTAUR HAVM ASSAY
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 17, 2008 |
| Received | Jun 18, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081716
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.