510(k) K081709 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
OLYMPUS AFP - ALPHA-FETOPROTEIN
| Applicant | Olympus Life Science Research Europa GmbH (Europa), O'Callaghans Mills, Co. Clare, IE |
| Decision | Substantially Equivalent, Mar 16, 2009 |
| Received | Jun 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081709
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.