K093458 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298. This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 4, 2009, 28 days after receiving the submission on November 6, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K093458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2009 |
| Decision Date | December 04, 2009 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |