K934539 is an FDA 510(k) clearance for the THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY. 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 March 30, 1994, 194 days after receiving the submission on September 17, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K934539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1993 |
| Decision Date | March 30, 1994 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GKL — Counter, Cell, Automated (particle Counter) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |