The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for Yellow Iris Tm.
| Device ID | K830220 |
| 510k Number | K830220 |
| Device Name: | YELLOW IRIS TM |
| Classification | Automated Urinalysis System |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-24 |
| Decision Date | 1983-06-17 |