K091153 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291. This device is classified as a Enzymatic, Carbon-dioxide (Class II - Special Controls, product code KHS).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on July 13, 2009, 83 days after receiving the submission on April 21, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K091153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2009 |
| Decision Date | July 13, 2009 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |