510(k) K093458 ยท JFY Enzymatic Method, Creatinine
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Dec 4, 2009 |
| Received | Nov 6, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2017 | Beckman Coulter Inc. Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298.
Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine. Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.