510(k) K091742 ยท JFY Enzymatic Method, Creatinine
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Aug 14, 2009 |
| Received | Jun 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091742
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Beckman Coulter Inc Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733 Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.