The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for The Yellow Iris Urinalysis Workstation With Iriscope Body Fluid Analysis Capability.
| Device ID | K934539 |
| 510k Number | K934539 |
| Device Name: | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 -5805 |
| Contact | Kenneth Langford |
| Correspondent | Kenneth Langford INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 -5805 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-17 |
| Decision Date | 1994-03-30 |