510(k) K073634 ยท JFY Enzymatic Method, Creatinine
MULTIGENT CREATININE (ENZYMATIC) ASSAY
| Applicant | SENTINEL CH. SpA, Milan, IT |
| Decision | Substantially Equivalent, Jun 19, 2008 |
| Received | Dec 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2017 | Sentinel CH SPA MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems
Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.