510(k) K132399 ยท JFY Enzymatic Method, Creatinine
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
| Applicant | Elitechgroup, Bothell WA, US |
| Decision | Substantially Equivalent, Jan 3, 2014 |
| Received | Aug 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132399
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.