K081992 is an FDA 510(k) clearance for the DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108. This device is classified as a Cyclosporine (Class II - Special Controls, product code MKW).
Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on August 5, 2008, 22 days after receiving the submission on July 14, 2008.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1235.
| 510(k) Number | K081992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2008 |
| Decision Date | August 05, 2008 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MKW — Cyclosporine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1235 |