The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for Yellow Iris Urinalysis Workstation W/iriscope Body Fluid Analysis Capability.
| Device ID | K954006 |
| 510k Number | K954006 |
| Device Name: | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Contact | Sanford Widran |
| Correspondent | Sanford Widran INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-25 |
| Decision Date | 1996-03-12 |