510(k) K081769 ยท JBQ Antithrombin Iii Quantitation
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, May 28, 2009 |
| Received | Jun 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081769
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.