K914256 is an FDA 510(k) clearance for the YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU. This device is classified as a Counter, Cell, Automated (particle Counter) (Class II - Special Controls, product code GKL).
Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on May 1, 1992, 221 days after receiving the submission on September 23, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K914256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1991 |
| Decision Date | May 01, 1992 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GKL — Counter, Cell, Automated (particle Counter) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |