The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for Iris Urine Stain.
| Device ID | K821503 |
| 510k Number | K821503 |
| Device Name: | IRIS URINE STAIN |
| Classification | Crystal Violet For Histology |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ICF |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-19 |
| Decision Date | 1982-06-03 |