510(k) K103376 ยท JFY Enzymatic Method, Creatinine
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
| Applicant | Seppim S.A.S., Bothell WA, US |
| Decision | Substantially Equivalent, Nov 18, 2011 |
| Received | Nov 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103376
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.