510(k) K072409 ยท JFY Enzymatic Method, Creatinine
AFINION ACR AND ACR CONTROL
| Applicant | Axis-Shield Poc AS, Rodelokka, Oslo, NO |
| Decision | Substantially Equivalent, Feb 12, 2008 |
| Received | Aug 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072409
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.